Senior Quality Assurance Manager
4 weeks ago
Transforming lives through innovative therapies and global impact.
PCI Pharma Services
We invest in people who drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of quality control.
To supervise the QC Inspectors and ensure operational requirements and company objectives are met.
Key Responsibilities:
- Organise the QC Inspectors to ensure core QC processes are operating in line with EU GMP standards and defined company's KPI's processes.
- Plan and schedule the QC Inspectors workload to meet operational schedules and ensure 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.
- Ensure 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.
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.
Be part of building the bridge between life changing therapies and patients.
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