Senior QA Specialist/Responsible Person
2 weeks ago
Looking for someone to support Senior Quality Manager/Responsible Person to manage all aspects of the Quality Management System to ensure that products are GxP compliant and inspection ready.
Responsibilities:
- Take ownership and provide support to the business on QMS processes (Deviations, CAPA & Change Controls) including Root Cause Analysis, Risk Assessment, Action completion and timely closure of records
- Management of GxP Change Controls including oversight, progression of records, trending, reporting & measuring process effectiveness
- Lead on the completion of Product Quality Review
- Completion of checks to confirm that products that have been imported into Great Britain and require QP certification are locally released
- Completion of Internal Audits
- Completion of External Vendor Audits
Requirements:
- 5+ years’ experience within the Pharmaceutical Industry
- 5+ years’ experience within a Quality role
- Experience as a Responsible Person for Import (RPi)
- Quality Management System Lead Auditor or Pharmaceutical GMP Lead Auditor Qualification
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