Lead Qualified Person

6 days ago

Manchester, United Kingdom Walker Cole International Full time

Walker Cole International is seeking a highly experienced Compliance Officer to join our team in the Pharmaceutical industry. As a Compliance Officer, you will be responsible for ensuring Good Manufacturing Practice (GMP) compliance for our site and focusing on 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 Oversight: Oversee and verify non-conformances and Out-of-Specification/Out-of-Trend (OOS/OOT) results in accordance with internal procedures.
  • GEMBA Walks: Lead on manufacturing floor GEMBA walks to ensure adherence to GMP standards.
  • Quality Support and Guidance: 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 Qualified Person (QP) on the license as defined in EU Directive 2001/83/EC and the Human Medicines Regulations.
  • Effective Communication: 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.

Walker Cole International is a leading Pharmaceutical manufacturer in Northern England. We are committed to delivering high-quality products and services to our customers.

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