Quality Assurance Specialist
Vor 6 Tagen
Join our team at TechFirm Industrial Services as:
QUALITY ASSURANCE SPECIALIST (w/m/d)
in the GMP environment here in Switzerland
Quality Assurance Specialist
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.
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