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CQV Engineer (Greenfield Project)

Stamford Consultants AG

Posted on Jan 8, 2021 by Stamford Consultants AG

Bern, Switzerland
Research
Immediate Start
Annual Salary
Contract/Project


Our client is looking to hire a CQV Engineer who will be part of the QA department and be responsible for the quality oversight of their biomanufacturing site


Responsibilities



  • Owns all quality related responsibilities for the commissioning and qualification activities of dedicated facilities, equipment, utilities and systems related to the GMP manufacturing of biologics.

  • Representative of QA Qualification in the project organization in regards to qualification/validation of facilities, utilities, equipment and systems (incl. computerized systems)

  • Support the transfer from the project into production phase and support the handover of the facility to Operation/QA Operation

  • Reviews and releases Qualification Documents (URS, Qualification Plan & Report, DQ/IQ/OQ/PQ Reports, etc.)

  • Representative of QA Qualification during FATs

  • Performs assessments and approvals of technical changes requests

  • Supports and approves quality risk analysis

  • Review & approve deviations reports


Qualifications



  • Bachelor, Master degree or PhD in biotechnology, chemistry, life science or related field

  • 5+ years of experience in the GMP regulated pharma industry within Quality Unit

  • 3+ years of experience related to Commissioning and Qualification (C&Q) of facilities, utilities, equipment and systems

  • Good understanding of cGMP regulations and Guidelines

  • Good understanding of (cGEP)

  • Strong problem-solving skill and attention to quality is a must

  • English & German fluency


Aerotek, an Allegis Group company. Allegis Group AG, Basel, Switzerland. Registration No. CHE-101.865.121. Aerotek is a company within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, 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 at allegisgroup.com/en-gb/privacy-notices.


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: 1054791505

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