QA Manager - GxP, 21 CFR Part 11 and EU GMP Annex 11.

Switzerland, Basel
£49.52 - £57.08 per hour
04 Jul 2019
01 Aug 2019
mc 24383
Mark Cussens
Full Time
Contract Type
Experience Level
Experienced (non-manager)
Our leading pharmaceutical client is currently looking for a QA Manager.

Job Responsibilities

* Provide assurance that GxP regulated computerized systems are suitably implemented and managed in accordance with Idorsia requirements and, where appropriate, in accordance with regulatory requirements.
* Provide 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.
* Apply advanced knowledge and experience to address complex issues.
* Review and/or create validation documents where appropriate.
* Act as a primary contact person 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.
* Perform and coordinate internal and external audits (e.g., vendor audit…) with regard to Computerized System Validation.
* Perform 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.

Candidate's Requirements

* 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.
* At least 7 years' experience in Computerized Systems Validation (CSV).
* Excellent written and verbal communication and interpersonal skills.
* Ability to work as an individual or as part of a team.
* Ability to work under pressure and prioritize tasks.
* Reliable and conscientious.

Key People is a specialist international recruitment consultancy with over 25 years' experience of working within the life sciences, biotech, healthcare and CRO industries. Our experienced and dedicated clinical research related consultants have a long history of success, excellent technical knowledge and a flexible, consultative focussed approach to recruitment.

Please contact Mark Cussens, Clinical Research Recruiter on
Tel: +44 1727 817623 or email:
Tel: +41 4350 86620 or email:

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