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.
- 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
- 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.