Walker Cole International has been exclusively retained to support a Pharmaceutical business based in the South East of England with their search for a Qualified Person. As a QP you will be a key part of managing the company's quality functions, performing batch release activities and acting as a mentor on site.
You will be responsible for:
- Perform QP certification and batch release in full compliance with EU GMP (Annex 16) and MHRA standards.
- Provide technical and regulatory leadership, ensuring continuous improvement of quality systems.
- Review and approve all manufacturing and analytical documentation prior to product release.
- Mentor and develop junior QA staff, promoting a strong culture of quality and compliance.
The successful candidate will have:
- Degree in Pharmacy, Chemistry, Biology, or related life sciences.
- Must be a Qualified Person (QP) under Directive 2001/83/EC and UK Human Medicines Regulations 2012.
- Degree in Pharmacy, Chemistry, or Life Sciences with extensive pharmaceutical QA and batch release experience.
- Strong knowledge of EU GMP, Annex 16, and experience managing inspections and regulatory compliance.
- Excellent leadership, communication, and mentoring skills with a focus on integrity and quality.
- Eligible to act as a Qualified Person under Directive 2001/83/EC (Article 49).
Quality Assurance | QA | Qualified Person | Pharmaceutical | CAPA | Corrective and Preventative Action | Quality | eQMS | PQS | Pharmaceutical Quality System | Batch Release | QP | GMP | Good Manufacturing Practice | QMS | Quality Management System | Operational | Commercial | QP |