Quality Manager + Responsible Person (RP)

Walker Cole International is searching for a Quality Manager + Responsible Person (RP) to join a large, well-established European pharmaceutical company at their UK subsidiary. As the Quality Manager + Responsible Person (RP) , you will be responsible for owning the QMS set up and maintenance whilst performing market release in United Kingdom.

Key Responsibilities:

• Perform role of Responsible Person (RP) & Responsible Person Import (RPi)
• Local QMS set-up and maintenance according to applicable regulations and corporate requirements.
• Perform the market release for the local market in accordance with Good Distribution Practice (GDP) guidelines.
• Product Quality Complaints management, Recall Management, Deviation Investigation, CAPA implementation.
• Vendor oversight including Quality Technical Agreements, Audit Scheduling and KPI Monitoring.
• Reduce and mitigate product risks, through effective self inspection schedule.
• Support initiatives to meet or exceed Quality objectives and contribute to continuous improvement planning and execution.

Key Requirements:

• Minimum degree education, ideally in a Life Sciences discipline.
• Industry experience specifically working as a named Responsible Person/RP
• Minimum 5 years of work experience in Quality Assurance, with at least 1 year in a managerial role.
• Technical knowledge of GxP guidelines, deviation & CAPA management, and audit readiness.

Quality Assurance | QA | Quality Assurance Manager | QA Manager | GxP | GDP | Good Distribution Practice | RP | Responsible Person | Biopharmaceutical | Pharmaceutical | Audit | EMA | MHRA