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

Key People

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Job ID :


Company Type :

Staffing Firms

Industry :


Education Level :


Address 1 :

Western Europe,--Basel,Basel,

Key Skills :

GxP, 21 CFR Part 11 and EU GMP Annex 11, computer system validation

Salary :

€59 - €68 per hour

Date Posted :

04 Jul, 2019

Company Name :

Key People

Location1 :


Job Category :

Quality Assurance Jobs

Experience :


Job Type:


Travel Amount:



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:

Key People is a recruitment company with a reputation for providing good value that's been built up over 20 years.
-We achieve results faster
-Our candidates really are a cut above
-We add greater value
We think it's because we're a private company driven by clients, not by shareholders.

For our candidates, we have developed relationships with thousands of clients nationwide and across Europe, who choose to recruit through Key People, so you'll have a wide choice of opportunities to further your career.

Company Name:

Key People


Catherine House,Adelaide Street


Staffing Firms


United Kingdom





less than 100




St Albans

Phone No. :

01727 817 626

Key People is a recognised leading supplier of staffing and recruitment services to the Pharmaceutical, Scientific & Biotech industry. The company has been operating for over 20 years and has an integrated team of qualified recruitment consultants averaging more than 7 years of recruitment experience. Each consultant is a specialist recruiter for their market area, so they can provide full market advice to candidates and clients alike.

For more information,visit

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