Hobson Prior are looking for a QA Manager to join a growing biopharmaceutical company in Switzerland, who focus on discovering, developing and bringing more pioneering medicines to patients.
- Deliver assurance that GxP regulated computerized systems are suitably implemented and managed in accordance with company requirements and in accordance with regulatory requirements.
- Deliver support, guidance and advice with regard to computerized system validation within GxP area, 21 CFR Part 11 and EU GMP Annex 11.
- Provide support, guidance and advice with regard to IT Infrastructure qualification to comply with GxP requirements.
- Determine regulations that are applicable to a computerized system and need for validation.
- Review and/or create validation documents where appropriate.
- Represent as first point of contact between the computerized system project team and Pharmaceutical Development Department.
- Act as the Pharmaceutical Development representative with regard to the update of the internal computerized systems inventory.
- Complete and coordinate internal and external audits with regard to Computerized System Validation.
- Complete and coordinate external audits with regard to IT Infrastructure and services qualification.
- Agree on Corrective/Preventive Actions following audits and follow up on adequate execution.
- Perform vendor postal assessment.
- Support CSV QA Team Leader in the preparation of the audit plan and Validation Master Plan.
- Use advanced knowledge and experience to address complex issues.
- Strong written and verbal communication and interpersonal skills.
- Capable to work as an individual or as part of a team.
- Able to work under pressure and prioritize tasks.
- Reliable and conscientious.
- University degree with suitable qualification in the pharmaceutical industry area.
- Good knowledge and understanding of regulatory requirements such as GxP & 21 CFR Part 11 and GAMP5 guidelines, EU GMP Annex 11.
- Minimum of 7 years’ experience in Computerized Systems Validation (CSV).
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.