Senior Quality Assurance Manager

2 months ago

Bridgend, Bridgend county borough, United Kingdom PCI Pharma Services Full time

**Life Changing Therapies. Global Impact.**

At PCI Pharma Services, we're committed to making a difference in the lives of patients around the world. Our global network of teams is dedicated to pioneering and shaping the future of pharmaceutical services.

**Our Investment is in People**

We believe that our people are our greatest asset. That's why we're looking for a talented Senior Quality Assurance Manager to join our team. As a key member of our Quality Control department, you'll play a critical role in ensuring that our operations meet the highest standards of quality and compliance.

**Key Responsibilities:**

  • Supervise a team of Quality Control Inspectors to ensure that core QC processes are operating in line with EU GMP standards and defined company KPIs.
  • Plan and schedule the QC Inspectors' workload to meet operational schedules and ensure that defined timescales are met.
  • Identify and implement efficiencies and improvements for QC Inspector processes to ensure that the QC department delivers expected internal and external customer service.
  • Ensure that Non-Conformance Reports and QC-related deviations/CAPA's are identified, completed, and closed within defined timescales.
  • Identify, initiate, and oversee QC Change controls.
  • Organize performance and training of QC Inspectors as per company personnel policies/procedures.
  • Formulate and maintain QC Inspectors' objectives, ensuring alignment against PCI and site business plans and objectives.
  • Ensure that all activities are carried out to GMP standards.
  • Support special projects, site priorities, and new project introductions for QC (as required).
  • Support audits within the QC area.
  • Cross-functional support with the Senior Despatch QC and QC Inspector role.
  • Assist QA with the investigation of customer complaints and deviations.

**Reporting Requirements:**

  • Monthly reports for the QC systems.
  • MRB reports.
  • Improvement projects.
  • QC Inspector schedules and staff rotas.
  • Training and development plans for QC staff.

**Join Our Team**

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