Qualified Person

2 weeks ago


UK, UK, United Kingdom Barrington James Full time

Job Title: Qualified Person (QP)

Location: London, United Kingdom

Schedule: Full-time, on-site


Overview:

An industry leading biotech company, seeking a highly skilled Qualified Person (QP) with extensive experience in Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP). The ideal candidate will 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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