QA/ QC Expert

£60000 - £61000 per annum
  1. Permanent
  2. Good Laboratory Practice (GLP)
  3. Switzerland
Stein, Switzerland
Posting date: 17 Apr 2021
37043

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.


Job Responsibilities

  • 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

To Apply

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

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