Quality Assurance Specialist. Bern / Berne. Suiza

Join our team at TechFirm Industrial Services as:

QUALITY ASSURANCE SPECIALIST (w/m/d)

in the GMP environment here in Switzerland!

We are looking for the following qualifications and experience:

**Core Responsibilities**

• Verification of the companies compliance with ISO/cGMP quality system requirements as well as knowledge of PICS Guide to Good Manufacturing Practices Part 1 and 2 or the EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use, including Annex 1.

• Provide immediate support to operations and quality control staff to address compliance related concerns (QA on-the-floor support).

• Make independent quality-related decisions based on regulatory and compliance knowledge and provide independent quality support to project teams. Audit internal quality system elements in manufacturing and operational support areas.

• Provide oversight for compliance of Change Controls, CA/PA and investigations, OOS and deviations.

• Perform external audits of suppliers/vendors/off-site facilities.

• Act as a customer interface during on-site audits, conference calls and other standard means of communication.

• Independently identify and manage special projects or QA compliance functions as agreed upon with QA management.

• Prioritize and manage a variety of projects simultaneously.

• May need to lead and direct the work of others.

• Review and approve validation documents.

• Review and Master Batch Records (MBR) and supporting documents.

• Perform review/release of batch records, as needed.

**Qualifications and Experience**

• Master or Engineering degree in Life science, Biotechnology or Pharmaceutical area

• Min. 3-5 years work experience

• Direct QA commercial drug substance/drug product experience required or an equivalent amount of aseptic processing and cell therapy manufacturing experience.

• GMP compliance and Part 11 compliance knowledge preferred.

• Experience with oversight of aseptic processing and the associated international aseptic processing regulations.

• Excellent written and oral communication to include accurate and legible documentation skills.

• Microsoft Office and database management skills, organization skills, record keeping skills and ability to handle multiple projects.

Interested to have a first chat and get on board at Techfirm? Then don't hesitate to submit your application together with your CV indicating your previous experience related to this position.