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      • tullamore, international
      • temporary
      • €55,000 - €60,000 per year
      • randstad financial services
      Role PurposeThe QA Specialist will play an active role in support of the general site quality system, and in addition, all 3rd party, regulatory, technology transfer, operational and audit initiatives.The QA Specialist will support the ongoing maintenance and continuous improvement of existing QA process and SOPs across all disciplines.Reporting StructureReporting to the Quality Operations Manager. Duties & ResponsibilitiesSupport the vendor management process to include vendor assessments, auditing and qualification. Support and participate in supplier change notification process for the site.Partake and contribute to internal and external audits and conduct on site audits as required. Analyse audit outcomes and implement appropriate corrective procedures.Prepare Quality agreements with required Vendors.Oversee and support site Material requirement specifications. Support site risk management procedures.Support change management, deviations and CAPA systems as required.Manage specific projects that may arise, in a timely and efficient manner. Support ongoing running and maintenance and additional requirements for Supplier management module of the Electronic tracking system ETS.Participate in ongoing set up of electronic systems where required.POSITION SPECIFICATIONQualifications, Experience, Skills, Knowledge and AttributesThird level Degree in a life science discipline.At least 2-3 years Biotech/Pharmaceutical QA experience with a strong knowledge of cGMP.Experience of interaction with cross-departmental teams.Excellent interpersonal and communication skills, meticulous eye for detail.Self-motivation.Computer literate.Strong time management awareness and the ability to drive projects forward. Randstad Financial & Professional encourage applications from individuals of all ages & backgrounds. Appointment will be made on merit alone but candidates must be able to demonstrate their ability to work in the UK. Randstad Financial & Professional acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
      Role PurposeThe QA Specialist will play an active role in support of the general site quality system, and in addition, all 3rd party, regulatory, technology transfer, operational and audit initiatives.The QA Specialist will support the ongoing maintenance and continuous improvement of existing QA process and SOPs across all disciplines.Reporting StructureReporting to the Quality Operations Manager. Duties & ResponsibilitiesSupport the vendor management process to include vendor assessments, auditing and qualification. Support and participate in supplier change notification process for the site.Partake and contribute to internal and external audits and conduct on site audits as required. Analyse audit outcomes and implement appropriate corrective procedures.Prepare Quality agreements with required Vendors.Oversee and support site Material requirement specifications. Support site risk management procedures.Support change management, deviations and CAPA systems as required.Manage specific projects that may arise, in a timely and efficient manner. Support ongoing running and maintenance and additional requirements for Supplier management module of the Electronic tracking system ETS.Participate in ongoing set up of electronic systems where required.POSITION SPECIFICATIONQualifications, Experience, Skills, Knowledge and AttributesThird level Degree in a life science discipline.At least 2-3 years Biotech/Pharmaceutical QA experience with a strong knowledge of cGMP.Experience of interaction with cross-departmental teams.Excellent interpersonal and communication skills, meticulous eye for detail.Self-motivation.Computer literate.Strong time management awareness and the ability to drive projects forward. Randstad Financial & Professional encourage applications from individuals of all ages & backgrounds. Appointment will be made on merit alone but candidates must be able to demonstrate their ability to work in the UK. Randstad Financial & Professional acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
      • tullamore, international
      • permanent
      • randstad financial services
      Duties & Responsibilities Perform testing of in-process, final product, and stability of drug substance and drug product samples using a suite of protein-specific analytical methods (CGE, SEC-HPLC, cIEF, ELISA) and general analytical methods (appearance analysis, pH, conductivity, etc.). Microbiological analysis including Environmental Monitoring, Endotoxin and Bioburden testing, growth promotion, and other associated tests. Support the technical transfer of analytical test methods to and from the Tullamore facility. ● Creation and revision of documents including test methods, SOPs, material requirement specifications, forms, and other quality system documentation to allow the execution of the analysis in a GMP environment. This will include trending data, monitoring Out of Specifications and participating in laboratory investigations. Work closely with the process development group to support the development of a robust manufacturing process. Work closely with specialist contract testing service providers to ensure excellent collaboration is maintained throughout the project. Support raw material testing (and outsourcing activities) to E.P./USP monographs when required for GMP manufacture. Input into the identification of equipment requirements and work with vendors to ensure execution of all deliverables, including equipment qualification and validation. Provide technical reports upon completion of QC projects. Participate in Quality and Safety regulatory audits. Qualifications, Experience, Skills, Knowledge and Attributes BSc, MSc in a relevant discipline (e.g. biochemistry, chemistry, process engineering) or equivalent experience. Minimum 1-year relevant experience in a GMP laboratory environment. Experience of the test methods commonly used in the analysis of proteins, including but not limited to ELISA, SEC-HPLC, CE-SDS, cIEF, and protein content by UV-Vis spectrophotometry. Knowledge of protein characterisation techniques is also desirable. Experience with Qualification and Validation of test methods. Proven ability to work independently in a laboratory. Ability to learn quickly and take responsibility for tasks/projects. Highly organised and structured approach to task completion. ● Excellent verbal and written communication skills, including ability to present work in clear, concise reports or presentations.Randstad Financial & Professional encourage applications from individuals of all ages & backgrounds. Appointment will be made on merit alone but candidates must be able to demonstrate their ability to work in the UK. Randstad Financial & Professional acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
      Duties & Responsibilities Perform testing of in-process, final product, and stability of drug substance and drug product samples using a suite of protein-specific analytical methods (CGE, SEC-HPLC, cIEF, ELISA) and general analytical methods (appearance analysis, pH, conductivity, etc.). Microbiological analysis including Environmental Monitoring, Endotoxin and Bioburden testing, growth promotion, and other associated tests. Support the technical transfer of analytical test methods to and from the Tullamore facility. ● Creation and revision of documents including test methods, SOPs, material requirement specifications, forms, and other quality system documentation to allow the execution of the analysis in a GMP environment. This will include trending data, monitoring Out of Specifications and participating in laboratory investigations. Work closely with the process development group to support the development of a robust manufacturing process. Work closely with specialist contract testing service providers to ensure excellent collaboration is maintained throughout the project. Support raw material testing (and outsourcing activities) to E.P./USP monographs when required for GMP manufacture. Input into the identification of equipment requirements and work with vendors to ensure execution of all deliverables, including equipment qualification and validation. Provide technical reports upon completion of QC projects. Participate in Quality and Safety regulatory audits. Qualifications, Experience, Skills, Knowledge and Attributes BSc, MSc in a relevant discipline (e.g. biochemistry, chemistry, process engineering) or equivalent experience. Minimum 1-year relevant experience in a GMP laboratory environment. Experience of the test methods commonly used in the analysis of proteins, including but not limited to ELISA, SEC-HPLC, CE-SDS, cIEF, and protein content by UV-Vis spectrophotometry. Knowledge of protein characterisation techniques is also desirable. Experience with Qualification and Validation of test methods. Proven ability to work independently in a laboratory. Ability to learn quickly and take responsibility for tasks/projects. Highly organised and structured approach to task completion. ● Excellent verbal and written communication skills, including ability to present work in clear, concise reports or presentations.Randstad Financial & Professional encourage applications from individuals of all ages & backgrounds. Appointment will be made on merit alone but candidates must be able to demonstrate their ability to work in the UK. Randstad Financial & Professional acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
      • tullamore, international
      • permanent
      • randstad financial services
      Role PurposeThis role within the Quality Control group will support all microbiological testing carried out by the analytical group- utilities and method qualification and routine monitoring, In-process, Drug Substance and Drug Product testing, stability testing and raw material testing.Reporting StructureReporting to The Quality Control Manager. Duties & ResponsibilitiesProvide Microbiological support to the siteDevelop, maintain and update microbiological methods, specifications and SOP's in compliance with quality and regulatory requirements to allow the execution of the analysis in a GMP environment. This will include trending data, monitoring Out of Specifications and participating in laboratory investigations.Testing of In-process, Drug Substance and Drug Product Batches manufactured.Co-ordinating all site Utilities testing-environmental monitoring and water testing programmes.Lead all environmental investigations, root cause analysis, and report close out.Lead monthly environmental review meetings and present all relevant trends to a cross departmental team.Provide annual contamination control training to all personnel. Provide aseptic technique training to all new employees.Validation of microbiological methods e.g. bioburden and endotoxin.Support autoclave validation programme.Stability testing of Drug Substance and Drug Product BatchesParticipate in Quality and Safety regulatory audits.Support raw material testing when required for GMP manufactureInput into the identification of equipment requirements and work with vendors to ensure execution of all deliverables, including equipment qualification and validation.Troubleshooting equipment and techniques within the Analytical team.Participation in other projects/duties as defined by the Quality Director POSITION SPECIFICATIONQualifications, Experience, Skills, Knowledge and AttributesThird level degree in a life Science discipline2-5 years' experience in a microbiology role with relevant experience in environmental monitoring and utilities testing, bioburden testing and endotoxin testing. Experience in validation of microbiological methods is also required. Strong analytical and technical skills Ability to learn quickly and take responsibility for tasks/projects.Highly organised and structured approach to task completion.Strong time management awareness and the ability to drive projects forward.Excellent verbal and written communication skills, including ability to present work in clear, concise reports or presentations. Randstad Financial & Professional encourage applications from individuals of all ages & backgrounds. Appointment will be made on merit alone but candidates must be able to demonstrate their ability to work in the UK. Randstad Financial & Professional acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
      Role PurposeThis role within the Quality Control group will support all microbiological testing carried out by the analytical group- utilities and method qualification and routine monitoring, In-process, Drug Substance and Drug Product testing, stability testing and raw material testing.Reporting StructureReporting to The Quality Control Manager. Duties & ResponsibilitiesProvide Microbiological support to the siteDevelop, maintain and update microbiological methods, specifications and SOP's in compliance with quality and regulatory requirements to allow the execution of the analysis in a GMP environment. This will include trending data, monitoring Out of Specifications and participating in laboratory investigations.Testing of In-process, Drug Substance and Drug Product Batches manufactured.Co-ordinating all site Utilities testing-environmental monitoring and water testing programmes.Lead all environmental investigations, root cause analysis, and report close out.Lead monthly environmental review meetings and present all relevant trends to a cross departmental team.Provide annual contamination control training to all personnel. Provide aseptic technique training to all new employees.Validation of microbiological methods e.g. bioburden and endotoxin.Support autoclave validation programme.Stability testing of Drug Substance and Drug Product BatchesParticipate in Quality and Safety regulatory audits.Support raw material testing when required for GMP manufactureInput into the identification of equipment requirements and work with vendors to ensure execution of all deliverables, including equipment qualification and validation.Troubleshooting equipment and techniques within the Analytical team.Participation in other projects/duties as defined by the Quality Director POSITION SPECIFICATIONQualifications, Experience, Skills, Knowledge and AttributesThird level degree in a life Science discipline2-5 years' experience in a microbiology role with relevant experience in environmental monitoring and utilities testing, bioburden testing and endotoxin testing. Experience in validation of microbiological methods is also required. Strong analytical and technical skills Ability to learn quickly and take responsibility for tasks/projects.Highly organised and structured approach to task completion.Strong time management awareness and the ability to drive projects forward.Excellent verbal and written communication skills, including ability to present work in clear, concise reports or presentations. Randstad Financial & Professional encourage applications from individuals of all ages & backgrounds. Appointment will be made on merit alone but candidates must be able to demonstrate their ability to work in the UK. Randstad Financial & Professional acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
      • tullamore, international
      • permanent
      • randstad financial services
      Role PurposeThis role within the Quality Control group will support all microbiological testing carried out by the analytical group- utilities and method qualification and routine monitoring, In-process, Drug Substance and Drug Product testing, stability testing and raw material testing.Reporting StructureReporting to The Quality Control Manager. Duties & ResponsibilitiesProvide Microbiological support to the siteDevelop, maintain and update microbiological methods, specifications and SOP's in compliance with quality and regulatory requirements to allow the execution of the analysis in a GMP environment. This will include trending data, monitoring Out of Specifications and participating in laboratory investigations.Testing of In-process, Drug Substance and Drug Product Batches manufactured.Co-ordinating all site Utilities testing-environmental monitoring and water testing programmes.Lead all environmental investigations, root cause analysis, and report close out.Lead monthly environmental review meetings and present all relevant trends to a cross departmental team.Provide annual contamination control training to all personnel. Provide aseptic technique training to all new employees.Validation of microbiological methods e.g. bioburden and endotoxin.Support autoclave validation programme.Stability testing of Drug Substance and Drug Product BatchesParticipate in Quality and Safety regulatory audits.Support raw material testing when required for GMP manufactureInput into the identification of equipment requirements and work with vendors to ensure execution of all deliverables, including equipment qualification and validation.Troubleshooting equipment and techniques within the Analytical team.Participation in other projects/duties as defined by the Quality Director POSITION SPECIFICATIONQualifications, Experience, Skills, Knowledge and AttributesThird level degree in a life Science discipline2-5 years' experience in a microbiology role with relevant experience in environmental monitoring and utilities testing, bioburden testing and endotoxin testing. Experience in validation of microbiological methods is also required. Strong analytical and technical skills Ability to learn quickly and take responsibility for tasks/projects.Highly organised and structured approach to task completion.Strong time management awareness and the ability to drive projects forward.Excellent verbal and written communication skills, including ability to present work in clear, concise reports or presentations. Randstad Financial & Professional encourage applications from individuals of all ages & backgrounds. Appointment will be made on merit alone but candidates must be able to demonstrate their ability to work in the UK. Randstad Financial & Professional acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
      Role PurposeThis role within the Quality Control group will support all microbiological testing carried out by the analytical group- utilities and method qualification and routine monitoring, In-process, Drug Substance and Drug Product testing, stability testing and raw material testing.Reporting StructureReporting to The Quality Control Manager. Duties & ResponsibilitiesProvide Microbiological support to the siteDevelop, maintain and update microbiological methods, specifications and SOP's in compliance with quality and regulatory requirements to allow the execution of the analysis in a GMP environment. This will include trending data, monitoring Out of Specifications and participating in laboratory investigations.Testing of In-process, Drug Substance and Drug Product Batches manufactured.Co-ordinating all site Utilities testing-environmental monitoring and water testing programmes.Lead all environmental investigations, root cause analysis, and report close out.Lead monthly environmental review meetings and present all relevant trends to a cross departmental team.Provide annual contamination control training to all personnel. Provide aseptic technique training to all new employees.Validation of microbiological methods e.g. bioburden and endotoxin.Support autoclave validation programme.Stability testing of Drug Substance and Drug Product BatchesParticipate in Quality and Safety regulatory audits.Support raw material testing when required for GMP manufactureInput into the identification of equipment requirements and work with vendors to ensure execution of all deliverables, including equipment qualification and validation.Troubleshooting equipment and techniques within the Analytical team.Participation in other projects/duties as defined by the Quality Director POSITION SPECIFICATIONQualifications, Experience, Skills, Knowledge and AttributesThird level degree in a life Science discipline2-5 years' experience in a microbiology role with relevant experience in environmental monitoring and utilities testing, bioburden testing and endotoxin testing. Experience in validation of microbiological methods is also required. Strong analytical and technical skills Ability to learn quickly and take responsibility for tasks/projects.Highly organised and structured approach to task completion.Strong time management awareness and the ability to drive projects forward.Excellent verbal and written communication skills, including ability to present work in clear, concise reports or presentations. Randstad Financial & Professional encourage applications from individuals of all ages & backgrounds. Appointment will be made on merit alone but candidates must be able to demonstrate their ability to work in the UK. Randstad Financial & Professional acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
      • tullamore, international
      • permanent
      • randstad financial services
      Why work for this company?Our client discovers, develops, manufactures and commercialises medicines, vaccines and diagnostic products, which are complemented by bio-devices, genetic tests and a range of services. Company Profile:65+ years of experience in healthNearly $6 billion annual revenues25 manufacturing sites around the world10,000 employees worldwide of which 1,100 employees are committed to R&DRole Purpose This role within the Manufacturing Department is responsible for leading all upstream processing activities within the manufacturing team. The Upstream Manager will lead and build the upstream team to ensure delivery of departmental Key Performance Indicators (KPIs) and will be responsible for all key activities pertaining to the commercial production process, based on mammalian cell culture, manufacturing recombinant monoclonal antibodies, for veterinary use. This role will involve highly collaborative interaction with other stakeholders to plan projects and timelines and coordinate activities. Reporting Structure Reporting to the Director of Manufacturing. Duties & Responsibilities Build, lead and develop a team with expertise specifically in the area of upstream cell culture processes using disposable technologies to execute routine manufacturing activities. ● Build schedule and resource plan to deliver manufacturing strategy. Supervise daily Upstream manufacturing activities and ensure production timelines are met, and GMP compliance is maintained. Scale-up and validate steps in the upstream process Maintain Batch Manufacturing Records, SOPs, and other quality system documentation to support GMP manufacture Ensure that the qualification and maintenance of equipment is up to date. ● Provide expert input into process validation programme, including, cell bank production and process risk assessment. Collaborate with QC & QA groups to ensure GMP compliance, manage deviation investigations and CAPA implementation, and support client auditing and agency inspections. ● Participate in Quality and Safety regulatory audits Identify continuous improvement initiatives and action plans to implement operational excellence and lean practices Ensure USP team is trained to ensure staff can perform manufacturing operations safely, compliantly and training records maintained. Motivate, retain, develop existing group members and recruit new staffs to build a strong Upstream manufacturing team Act as a role model for the Manufacturing function and also the wider organisation in adherence to the core beliefs. POSITION SPECIFICATION Qualifications, Experience, Skills, Knowledge and Attributes BSc, MSC, PhD in a relevant discipline (e.g. biochemistry, chemistry, processUpstream Snr. Manager engineering) or equivalent experience. At least 5 years' relevant experience in bioprocess development and/or manufacturing, specifically on large scale mammalian cell culture / bioreactor systems. * Demonstrates critical thinking skills in problem solving and decision making. * Excellent written and oral presentation skills with a clear understanding of process control strategy and data management. Strong leadership competencies with demonstrated management skills * Self-motivated, flexible and creative leader, able to prioritize, multi-task, and work in a fast-paced & demanding environment. Experience in dealing with FDA/HPRA and have a solid understanding of quality systems in terms of deviations, investigations, CAPA's and change controls. Randstad Financial & Professional encourage applications from individuals of all ages & backgrounds. Appointment will be made on merit alone but candidates must be able to demonstrate their ability to work in the UK. Randstad Financial & Professional acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003
      Why work for this company?Our client discovers, develops, manufactures and commercialises medicines, vaccines and diagnostic products, which are complemented by bio-devices, genetic tests and a range of services. Company Profile:65+ years of experience in healthNearly $6 billion annual revenues25 manufacturing sites around the world10,000 employees worldwide of which 1,100 employees are committed to R&DRole Purpose This role within the Manufacturing Department is responsible for leading all upstream processing activities within the manufacturing team. The Upstream Manager will lead and build the upstream team to ensure delivery of departmental Key Performance Indicators (KPIs) and will be responsible for all key activities pertaining to the commercial production process, based on mammalian cell culture, manufacturing recombinant monoclonal antibodies, for veterinary use. This role will involve highly collaborative interaction with other stakeholders to plan projects and timelines and coordinate activities. Reporting Structure Reporting to the Director of Manufacturing. Duties & Responsibilities Build, lead and develop a team with expertise specifically in the area of upstream cell culture processes using disposable technologies to execute routine manufacturing activities. ● Build schedule and resource plan to deliver manufacturing strategy. Supervise daily Upstream manufacturing activities and ensure production timelines are met, and GMP compliance is maintained. Scale-up and validate steps in the upstream process Maintain Batch Manufacturing Records, SOPs, and other quality system documentation to support GMP manufacture Ensure that the qualification and maintenance of equipment is up to date. ● Provide expert input into process validation programme, including, cell bank production and process risk assessment. Collaborate with QC & QA groups to ensure GMP compliance, manage deviation investigations and CAPA implementation, and support client auditing and agency inspections. ● Participate in Quality and Safety regulatory audits Identify continuous improvement initiatives and action plans to implement operational excellence and lean practices Ensure USP team is trained to ensure staff can perform manufacturing operations safely, compliantly and training records maintained. Motivate, retain, develop existing group members and recruit new staffs to build a strong Upstream manufacturing team Act as a role model for the Manufacturing function and also the wider organisation in adherence to the core beliefs. POSITION SPECIFICATION Qualifications, Experience, Skills, Knowledge and Attributes BSc, MSC, PhD in a relevant discipline (e.g. biochemistry, chemistry, processUpstream Snr. Manager engineering) or equivalent experience. At least 5 years' relevant experience in bioprocess development and/or manufacturing, specifically on large scale mammalian cell culture / bioreactor systems. * Demonstrates critical thinking skills in problem solving and decision making. * Excellent written and oral presentation skills with a clear understanding of process control strategy and data management. Strong leadership competencies with demonstrated management skills * Self-motivated, flexible and creative leader, able to prioritize, multi-task, and work in a fast-paced & demanding environment. Experience in dealing with FDA/HPRA and have a solid understanding of quality systems in terms of deviations, investigations, CAPA's and change controls. Randstad Financial & Professional encourage applications from individuals of all ages & backgrounds. Appointment will be made on merit alone but candidates must be able to demonstrate their ability to work in the UK. Randstad Financial & Professional acts as an employment agency for permanent recruitment & an employment business for temporary recruitment as defined by the Conduct of Employment Agencies & Employment Business Regulations 2003

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