Qualified Person

Walker Cole International are searching for a Qualified Person (QP) to join a Pharmaceutical company based in the North East. As the QP, you will be instrumental in acting as a SME to ensure site compliance and performing routine batch release duties of commercial small molecule products.

Your responsibilities will be to:

• Act as an expert in QA processes and an advisor to Senior QA Management.
• Build and maintain relationships with internal and external stakeholders to support business growth and development.
• Act as a QP per EU Directives 2001/83/EC, 2001/82/EC, 2001/20/EC and Regulation 536/2014 as required.
• Oversee manufacturing activities on site as well as investigate deviations, CAPAs, and perform root cause analysis.

The successful candidate will:

• Have a degree in a Life Sciences degree
• Be eligible to act as a Qualified Person as per Directive 2001/83/EC.
• 5-8 years of hands on QA experience within a GxP Pharmaceutical environment.
• Strong working knowledge and interpretation/implementation of GxP requirements.

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 |