BRINE SA is currently looking for a Compliance Manager for our Client in Basel.
- Coordinates and compiles APRs/PQRs in accordance with GMP requirements and ensures that follow-up activities are defined, carried out and reported
- Supporting of diverse IT systems, ex DMT, RMT, Agile CCEX, SAP and others in a QA CPL Role
- Maintains relevant SOPs, supports for GMP training
- Supports/Leads Self Inspections (as Lead auditor or Co-Auditor) and execution of Health Authority Inspections, Customer Audits and Internal inspections
- Initiates and leads quality improvement projects
- Coordinates local implementation of Client Quality Manuals and GOPs
- (Technical) University or academic degree in Chemistry, Biology, Pharmacy or equivalent
- Post graduate diploma in business administration or equivalent
- Professional experience in Quality Control / Quality Assurance or in the manufacturing of pharmaceutical drug products and Steriles / Biotechnology
- Profound knowledge of cGMPs
- Proven track record with FDA, EMEA and other Health Authorities.
- Strong understanding of risk assessment and risk management fundamentals/tools Minimum requirements
- Pharma Know-How REQUIRED ! .
- Fluent in German and English (spoken and written) REQUIRED !
To learn more about this opportunity please send your CV ASAP in Word format to Brine SA.
Work location: Stein
Start: June 1st 2018
Duration: till May 31st 2019
Salary: Local Market rate according to experience
Permit: EU permits
Ref. Nr.: HS2444