Senior Quality Assurance Specialist

7 days ago

Manchester, United Kingdom Walker Cole International Full time

Walker Cole International is seeking a highly experienced Senior Quality Assurance Specialist to join our team as the Lead Qualified Person (QP) for a leading Pharmaceutical manufacturer in the UK. As the Lead Qualified Person, you will be responsible for ensuring Good Manufacturing Practice (GMP) compliance for the site and overseeing the release of small molecule batches.

Key Responsibilities:

  • Batch Certification and Release: Ensure the certification and release of licensed products manufactured on site and through third-party Contract Manufacturing Organizations (CMOs).
  • Non-Conformance and OOS/OOT Management: Oversee and verify non-conformances and Out-of-Specification/Out-of-Trend (OOS/OOT) results in accordance with internal procedures.
  • GEMBA Walks and Quality Assurance: Lead on manufacturing floor GEMBA walks and provide support, guidance, and advice on Quality matters to all departments within the company, contributing to the company's GMP strategy.

Requirements:

  • Quality Assurance Experience: Extensive experience in Quality Assurance roles within the Pharmaceutical industry, with on-site manufacturing experience preferred.
  • Qualifications and Experience: The qualifications and experience required to be a named QP on the license as defined in EU Directive 2001/83/EC and the Human Medicines Regulations.
  • Communication and Collaboration: Effective communication skills to allow collaboration and engagement with all stakeholders across the business.
  • Agility and Flexibility: A willingness to be agile and flexible to enable them to adapt to situations when required.

About Walker Cole International:

Walker Cole International is a leading recruitment agency specializing in the Pharmaceutical and Life Sciences industries. We are committed to providing exceptional recruitment services to our clients and candidates.

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