Senior Quality Assurance Manager

4 weeks ago


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

Life-changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI Pharma Services.

Our investment is in people who make an impact, drive progress, and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

To supervise the QC Inspectors to meet operational requirements and company objectives.

:

  • Organise the QC Inspectors to ensure core QC processes are operating in line with EU GMP standards and defined company's KPI's processes as follows: Incoming inspection, Master label proofs, Label inspection, In-process checks and finished product inspection, Retains process, Material review board
  • Planning and scheduling the QC Inspectors workload to meet operational schedules and ensuring defined timescales are met.
  • Identify and implement efficiencies and improvements for QC Inspector processes to ensure the QC department delivers expected internal and external customer service.
  • Ensure Non-Conformance Reports and QC related deviations/CAPA's are identified, completed and closed within defined timescale's.
  • Identify, initiate and oversee QC Change controls
  • Organise 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.
  • Ensuring that all activities are carried out to GMP.
  • Support special projects, site priorities and new project introductions for QC (as required).
  • Support audits within QC area
  • Cross functional support with the Senior Despatch QC and QC inspector role
  • Assist QA with the investigation of customer complaints and deviations.

:

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

Be part of building the bridge between life-changing therapies and patients.



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