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. They serve veterinarians, livestock producers and people who raise and care for farm and companion animals in more than 100 countries.
Company Profile65+ years of experience in animal healthNearly $6 billion annual revenues25 manufacturing sites around the world10,000 employees worldwide of which 1,100 employees are committed to R&D
Responsibilities:Evaluation, Approval & Monitoring of vendors including Quality Agreements (End to End Supplier Approval and Management).Provide QA support to Operations in terms of ensuring that GMP activities are in compliance with regulatory,corporate and site procedures.Provide QA support for Deviations, CAPA's, Change Control, Cleaning Validation and Quality reviewer of SOPs, EOPs, Change Requests, Protocols, Reports, etc.Review /Approve Master Batch Record (MBR), Review Batch Records / Review Cleaning Records as per the site procedures.Perform/Lead Internal Audits/Quality Walkthroughs.Quality Oversight of Warehouse and GMP Service Providers.Manage Vendor audits from planning to close out.Support Internal Inspection Readiness, Corporate and Regulatory Inspections.Management of Regulatory Changes.Support continuous improvement initiatives, ensuring quality is built in and all corporate and regulatory requirements are met.Serving as a quality culture role model and in still a strong quality and compliance culture across the site.Assure the use of operational excellences tools in quality procedures and processes.Support the development of quality goals and targets as part of the organisation's strategic plan.Drive continuous improvement initiatives which positively impact cycle time, productivity, efficiency and quality of work through Lean methodology. Active participation in site Tier meetings.Comply with the relevant Safety Statutory provisions, and in particular must take reasonable care for their own safety and that of others who may be affected by their acts or omissions at work.All employees must comply with the site's safety rules and instructions, and must report all accidents, injuries, defects or situations which they believe could present a hazard to themselves or others.
Education:Undergraduate degree in pharmaceutical, biological or chemical sciences.Relevant advanced degree preferred.10+ years relevant experience in Pharmaceutical and/or Animal Health industry, with a current knowledge of cGMP's and regulatory guidance required.Significant experience in QA supplier management and ISO 9001 and or Regulatory Affairs is desirable.Success in developing, implementing and maintaining Quality Systems and Standards at manufacturing site level in accordance with ICHQ10 key principles.ICHQ7 Manufacturing Site experience preferred.Recognised LSS Qualification (Yellow belt, Green Belt, Black Belt) desirable.
Desired Competencies:Demonstrated knowledge and success in working with cross functional teams e.g. supplier management.Ability to develop and adhere to self-directed standard work- organised and methodical with ability to take initiative with minimal guidance and be comfortable working both as an individual and as part of a team.Exercises Good Judgement and Drives Change for Competitive Advantage.Strong written and oral communication skills and ability to collaborate effectively with others.Strong interpersonal, leadership and influencing Skills, communication and motivation.
Due to a high volume of applications only those being progressed to the next stage will be contacted
Randstad encourage applications from individuals of all ages & backgrounds. Whilst appointments will be made on merit alone candidates must be able to prove their right to work in the UK or the Republic of Ireland (as relevant). Randstad 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...