Senior GDP Quality Specialist

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