Lead Qualified Person (QP)

Walker Cole International is searching for a Lead Qualified Person (QP) to join a leading Pharmaceutical manufacturer in Northern England. As the Lead Qualified Person, you will ensure GMP compliance for the site and focus on the release of small molecule batches.

Your responsibilities as the Qualified Person will be:

• The batch certification and release for licensed products manufactured on site and through third party CMOs.
• To oversee and verify non-conformances and OOS/OOTs in accordance with internal procedures.
• To lead on manufacturing floor GEMBA walks.
• To provide support, guidance and advice on Quality matters to all departments within the company, contributing to the company GMP strategy.

The successful candidate for the Qualified Person position will demonstrate the following:

• Extensive experience in Quality Assurance roles within the Pharmaceutical industry, with on-site manufacturing experience preferred.
• 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.
• Effective communication skills to allow collaboration and engagement with all stakeholders across the business.
• A willingness to be agile and flexible to enable them to adapt to situations when required.

Quality Assurance | QA | QP | Qualified Person | Deviations | OOS | OOT | GEMBA | GMP | Good Manufacturing Practice | Orange Guide | Small molecule