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Validation Lead

Validation Lead

Pharmaceutical / Biotechnology / Chemical
  • Temporary full time
  • Reference : INT-029043
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Details

  • Region Basel
  • Type of contract Temporary full time
  • Sector of activity Pharmaceutical / Biotechnology / Chemical

Introduction

As a preferred supplier for Roche Basel in Kaiseraugst, we are looking for an individual as

Validation Lead

(contract until 31.08.2022). The earliest start date is asap or within one month. Home Office and fully remote, both possible.

Description of the mission

  • Coordinates with Business owners and SMEs, IT representatives, and Quality to assess, scope, plan, lead, and complete validation activities
  • Complete and drive completion of SRA
  • Participate in business process requirements analysis
  • Author validation plans
  • Review and conduct requirements traceability to specifications
  • Review test plans to ensure testing strategy is created based on importance of the system
  • Coordinate with testing team and or supervise and lead test development, dry-running, execution, and post-execution review
  • Author validation summary reports
  • Review CSV deliverables not directly authored by the Validation Lead
  • Deliver developed trainings to ensure that team members understand validation practices
  • Participate in IT change control as a validation representative


Required profile

  • Min. Bachelor degree in Computer Sciences or similar
  • Min. 7+ years of experience as Validation Lead in a Pharmaceutical, Biotech or Healthcare company in combination with project management experience
  • Min. 5 years of experience in CSV, preferred in the pharmaceutical industry
  • Hands on experience in validation testing and understanding of tasks
  • Work experience with standards such as 21 CFR 820, 21 CFR 11, and ISO 13485
  • English fluent (spoken and written), German is a plus
  • Leadership skills and experience in technical management within a matrix environment
  • Influence without authority
  • Proactive problem-solving skills
  • Strong coachingmentoring skills


Nice to Haves:

  • Previous Roche experience


Application process

Interested? You can find more information here: Infopackage. Please apply via the "Bewerben" button below and answer all questions, otherwise we will be unable to process your application.

Information

  • Reference INT-029043
  • Published on 2 mai 2022
  • ConsultantMarijke van Engelenburg