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Walker Cole International are currently supporting a Global Biopharmaceutical Company with a Senior GDP Quality Specialist (RP/RPi).
You will be responsible for:
- Ensure that the Quality Management System (QMS) is maintained, according to Good Distribution Practice (GDP).
- Perform self-inspections and internal audits, host regulatory inspections, and perform audits.
- Ensure timely resolution of change controls and deviations, including root cause analysis and CAPA management.
- Contribute to site management, ensuring that health and safety, security and temperature are monitored and controlled.
The successful candidate will have:
- Extensive experience in a Quality Management Systems (QMS) and Good Distribution Practice (GDP) compliance role.
- Proven experience working in the pharmaceutical industry.
- Experience of Auditing in a pharmaceutical setting.
Desirable Criteria:
- Previous experience named as Responsible Person (RP) on a WDA.
- Lead auditor qualification.
Quality Assurance | QA | GDP | Good Distribution Practice | RP | Responsible Person | Pharmaceutical | Audit | Self- Inspection |WDA | MHRA | Change Control | CAPA | Deviations | Root Cause Analysis | vendor audits | Supplier audits | internal audits | complaints | RCA
