The Rathdrum QA Specialist-Batch Release will have responsibility for ensuring that the process for the release of API Batches and release itself is in compliance with cGMP and the associated regulatory and registration requirements.
The QA Specialist- Batch Release may be required to perform tasks required by QA Specialist - QSS or QA Specialist - Operations on a case by case basis where needed, once trained to do so
Key objectives of this position include:
- Final Review of Check of Batch Documentation prior to final release - including but not limited to:
- Compilation of batch genealogy
- Assurance of approval of all input materials
- Assurance of closure of all associated change controls
- Assurance of closure of all associated Deviations and Lab investigations
- Final review and approval of Executed Batch Record
- Final review and approval of Executed Analytical Record
- Coordinate the Annual Product Review programme
- Support investigations as Required
- Ensure adherence to Regulatory Dossier Requirements
Common Responsibilities for all Quality Colleagues
- Active participation in site Tier meetings
- Perform/Lead Internal Audits/Quality Walkthroughs.
- Support Internal Inspection Readiness, Corporate and Regulatory Inspections.
- Drive continuous improvement initiatives which positively impact cycle time, productivity, efficiency and quality of work through Lean methodology, ensuring quality is built in and all corporate and regulatory requirements are met
- Serving as a quality culture role model and instil 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,
- 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.
- Required to safeguard company assets and ensure that all resources are expended or consumed in a prudent manner.
EDUCATION AND EXPERIENCE
- Undergraduate degree in pharmaceutical, biological or chemical sciences
- Relevant advanced degree preferred
- 5+ years relevant experience in Pharmaceutical and/or Animal Health industry, with a current knowledge of cGMP's and regulatory guidance required.
- QP Qualification - or desire to become QP Qualified preferred
- 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
TECHNICAL SKILLS AND COMPETENCIES REQUIRED
- 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.
- Drives for Superior Results and Passion to Win with demonstrated record in getting things done
- Inspires Continuous Improvement and Breakthrough Thinking - flexible and adaptable to new and innovative ideas.
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...