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CSV QA Manager

Actalent

Posted on Nov 4, 2022 by Actalent

Basel, Switzerland
Research
Immediate Start
Annual Salary
Contract/Project

Senior CSV QA Manager

Main requirements:

  • Ensure the compliance of the Computerized system used within the company
  • Act as a primary contact person between the computerized system project team and Pharmaceutical Development Department
  • Provide support, guidance and advice with regard to computerized system validation within GxP area, 21 CFR Part 11 and EU GMP Annex 11
  • Act as the Pharmaceutical Development representative with regard to the update of the internal computerized systems inventory
  • Act as Lead Auditor to ensure the compliance along the Computerized system life cycle.
  • Support CSV QA Team Leader in the preparation and the management of QS Documents relating to CSV QA and Data Integrity activities

Main Requirements:

  • Master's degree/Advanced University degree with suitable qualification in the pharmaceutical industry area
  • At least 7 years experience in Computerized Systems Validation (CSV)
  • Good knowledge and understanding of regulatory requirements such as GxP & 21 CFR Part 11 and GAMP5 guidelines, EU GMP Annex 11
  • Good knowledge and understanding of Data Integrity expectations and regulations in pharmaceutical industry

If you would like to learn more about this opportunity, feel free to reach out directly to (see below) .

Job Title: CSV QA Manager

Location: Basel, Switzerland

Job Type: Contract

Aerotek and Actalent Services, an Allegis Group company. Allegis Group AG, Basel, Switzerland. Registration No. CHE-101.865.121. Aerotek and Actalent Services are companies within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Actalent Services, Aston Carter, EASi, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice available on the website.

To access our Online Privacy Notice, which explains what information we may collect, use, share, and store about you, and describes your rights and choices about this, please go to the website.

We are part of a global network of companies and as a result, the personal data you provide will be shared within Allegis Group and transferred and processed outside the UK, Switzerland and European Economic Area subject to the protections described in the Allegis Group Online Privacy Notice. We store personal data in the UK, EEA, Switzerland and the USA. If you would like to exercise your privacy rights, please visit the "Contacting Us" section of our Online Privacy Notice for details on how to contact us. To protect your privacy and security, we may take steps to verify your identity, such as a password and user ID if there is an account associated with your request, or identifying information such as your address or date of birth, before proceeding with your request. If you are resident in the UK, EEA or Switzerland, we will process any access request you make in accordance with our commitments under the UK Data Protection Act, EU-U.S. Privacy Shield or the Swiss-U.S. Privacy Shield.

Reference: 1782433706

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