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CSV Specialist

Actalent

Posted on Apr 19, 2022 by Actalent

Lausanne, Vaud, Switzerland
Research
Immediate Start
Annual Salary
Contract/Project

Description:

Our client is looking for a CSV Senior Officer specialised in Clinical Development to join their growing team and contribute to the drug development activities related to innovative treatments in Oncology and Anti-infectives.

Main responsibilities:

  • Create key CSV deliverables and/or assist business units in writing CSV documentation (eg, Validation Plan, Functional Requirements Specification, Test Scripts, Validation Report), based upon approved templates/processes and ensures proper filing in respective document management system.
  • Review vendor validation documentation and provide documented feedback and guidance.
  • Execute Impact/Risk Analysis and document respective outcome.
  • Support the analysis and monitoring of security processes and incidents.
  • Support maintenance of eg, system inventories, changes, incidents, etc, ensuring accuracy and completeness at all times.
  • Provide CSV training as appropriate for users of specific systems.

Requirements:

  • At least a Bachelor in Sciences or in IT with 5-6 years working experience as CSV in the pharmaceutical industry
  • CSV Experience in a GCP environment
  • Excellent writing skills for scientifically sound technical documents, instructions, validation protocols and reports in English, French is an asset
  • Working knowledge of related regulatory requirements in the life sciences industry (GAMP 5, 21 CFR part 11, ...)

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

Job Title: CSV Specialist

Location: Lausanne, 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: 1569860300

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