QA/ QC Expert
An exciting opportuntiy has arisen for a QA/QC Expert to responsible for audits and ensures the product integrity and that standards are being met. A good QA specialist will know how to troubleshoot systems to ensure reliability, usability and performance.
- On-time and GMP-compliant release decisions for dosage forms (bulk and finished product, biotech DS) according to the product range of the Process Unit, for which QA-Stein Steriles has the decision-making responsibility.
- GMP-compliant assessment and decision of deviation reports (AWMs) for dosage forms (bulk and finished product), with escalation according to SOP
- Independently answer and process customer and regulatory inquiries.
- Ensuring the correct and timely preparation as well as dispatch of Certificates of Analysis (CoAs); in particular, special clarifications in case of problematic cases
- Active tracking of deadlines regarding release and escalation in case of any delays within the respective process unit
- Support and execution of internal and external audits and self-inspections
- Collaboration in the preparation of annual reports
- Collaboration on department-specific tasks such as queries, committees, working groups, etc.
- Creation and à-jour keeping of SOPs, which concern the own area of responsibility
- Additional tasks as delegated by the supervisor
Skills and Requirements
- University degree in chemistry/pharmacy/biology/medicine, knowledge of galenics, good GMP skills, IT skills (MS Office package), good knowledge of Pharm Ops CH, Novartis Pharma procedures.
- German and English spoken and written
- Several years of experience in pharmaceutical quality control, quality assurance or production
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.