Quality Assurance Lead
3 weeks ago
Barrington James is seeking a highly skilled Qualified Person (QP) to play a pivotal role in ensuring quality and compliance in our manufacturing and operational processes.
Key Responsibilities:
- Lead the manufacturing, testing, and release of product batches, ensuring strict GMP compliance at every stage.
- Oversee quality assurance across critical areas such as Manufacturing, Tech Transfer, Quality Control, and Supply Chain, ensuring seamless operations.
- Proactively identify and mitigate quality risks, driving swift and effective resolution of compliance issues.
- Lead Quality Management Review meetings, ensuring timely resolution of quality incidents, deviations, and customer complaints.
- Mentor and develop the QA team, including new Qualified Persons (QPs), providing expert training on GMP standards and best practices within the QMS framework.
- Drive continuous improvement initiatives to optimise the efficiency, robustness, and scalability of quality systems.
Key Competencies:
- Extensive expertise in GMP and pharmaceutical Quality Assurance, with a proven track record of maintaining compliance and operational excellence.
- Demonstrated ability to optimise Quality Management Systems (QMS), ensuring robust processes that meet regulatory standards and business objectives.
- Specialised knowledge in gene therapy and cell culture manufacturing, with experience in preparing for and managing regulatory inspections.
- Strong interpersonal and communication skills, combined with hands-on leadership to inspire teams and promote collaboration.
- Highly adaptable to the evolving needs of the business, with a commitment to embedding a culture of quality throughout the organisation.
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Quality Assurance Specialist
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