Senior QA Expert

Senior QA Expert, Inspection Management -6 month's contract Switzerland, Basel

Responsibilities:

- Maintains the Annual Inspection/Audit Schedule for the department/manufacturing site
- Leads and coordinates the preparation and execution of Health Authority Inspections, Customer's Audits and Internal inspections
- Coordinates the timely preparation of written responses to inspection/audit reports and ensures that adequate corrective and preventive actions are defined and implemented on time.
-Compiles annually the Site Quality Plan (SQP) and regularly monitors progress of each project against the associated timelines
-Manages the non-batch related quality aspects of contract manufacturing (reverse contractors)
- Ensures that a valid Quality agreement is in place in line with the requirements of the Global template, which clearly defines cGMP roles and responsibilities
- Ensures that all aspects of the handling, manufacturing and distribution of supplied products are in compliance with the Quality Manual, the effective Quality Agreement, that they meet relevant cGMP regulatory requirements and are conducted according to local SOPs
- Writes/Reviews/Approves SOPs

Requirements:

Technical University degree (chemistry, pharmacy/other related field)

- experience in quality control/quality assurance and in the manufacturing of pharmaceutical drug products
-Profound knowledge in cGMPs
- Proven track record with FDA, EMEA and other Health Authorities.
-Strong understanding of risk assessment and risk management fundamentals/tools
-Technical understanding of pharmaceutical/biological processes
- Extensive auditing experience
- English language is essential, German is an asset

Michael Bailey International is acting as an Employment Business in relation to this vacancy.