Global GMP Compliance Auditor

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  1. Permanent
  2. English
  3. Director
  4. Legal, Regulatory & Compliance
  5. Basel
  6. Healthcare & Life Sciences
  7. GMP Compliance, Audit, GMP Regulatory, Regulatory Inspection Management, Remediation, Risk Management, Quality Standards and Processes
Our client is a leading life sciences group.

On behalf of our clients, Swisslinx is looking for a Global GMP Compliance Auditor who is also experienced in regulatory inspection management to join their team in Basel.

Your mission

- Plan and execute GMP compliance audits, communicate deficiencies and risks and advise on remediation actions
- Support sites in regulatory inspection management, conduct mock inspections and provide input to responses following regulatory inspections
- Provide expertise to the group on new GMP regulatory requirements
- Act as a compliance reviewer and approver for GMP procedures and policies

Your background

- MSc in pharmacy, chemistry, biologics or equivalent
- Previous experience working as a GMP Auditor and solid expertise in regulatory inspection management
- Excellent knowledge of international GMP regulations and guidelines for drug products including aseptic manufacturing, APIs, medical devices and excipients
- Strong experience in remediation, GMP quality management concepts and risk management
- Fluency in English, any other language is a plus
- Ability to travel (up to 50%)

What’s on offer

This role will ideally suit an experienced GMP Compliance Auditor who possesses a solid operational experience in Quality Assurance or previously worked as a Regulator.

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