Qualification Validation engineer

null, null, ch
Company: Mantu
Category: Architecture and Engineering Occupations
Published on 2021-06-23 04:13:19

To extend our team in Switzerland, we are looking for a Qualification & Validation Engineer, to perform validation and qualification activities. you will be in charge of assuring compliance of these activities with cGMP as well as with internal policies and procedures.

Responsabilities:

  • May be assigned Subject Matter Expert role for a defined validation/qualification area.
  • Develop and justify the validation approach based on risk and scientific rational
  • Ensure equipment, systems and processes are qualified, validated and maintained in compliance with local policies, guidelines, and procedures.
  • Author and when required review validation documents, including requirement specifications, validation plans, protocols, reports, traceability matrix and summary reports.
  • Contributes to the development and maintenance of the site procedures.
  • Lead risk assessments and risk management teams
  • Review change controls and maintenance interventions, evaluating the impact upon qualified systems & validated processes, and documents required actions
  • Co-ordinate qualification and validation execution activities, including external vendors and internal departments.
  • profile:

  • 5 years experience in pharmaceutical Validation or related field
  • BS/MS in Engineering/Technical discipline or equivalent experience
  • Experience in project management 
  • Communicates pro-actively and collaboratively
  • Team player: ability to interact effectively with team and customers
  • Good level of English
  • Ability to communicate in French
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