Qualification and Validation Manager

vor 2 Wochen


Basel, Schweiz Randstad (Schweiz) AG Vollzeit
Jobdescription

For our client, we are seeking a highly skilled Qualification and Validation Manager to join their team in the Basel area on a temporary contract via Randstad. This position offers the opportunity to work in a GMP-relevant environment, focusing on CSV (Computerized System Validation) and qualification programs in pharmaceutical manufacturing.

Key Information:

  • Start Date: 01.02.2025
  • Latest Start Date: 01.04.2025
  • Contract Duration: Until 31.10.2025 (no extension planned)
  • Location: Basel area
  • Workload: 80-100%
  • Home Office: Maximum 20% (1 day per week)
  • Work Environment: GMP-relevant

Your Responsibilities:

  • Manage and coordinate CSV and qualification projects.
  • Develop qualification strategies, risk analyses, qualification plans, and reports.
  • Review and approve qualification plans, reports, and CA lists.
  • Coordinate and document global change requests and deviation management.
  • Prepare GMP documentation, including SOPs and validation documents.
  • Implement improvements for equipment and system qualification concepts.
  • Manage risk analyses (QRM - Quality Risk Management).
  • Support audits and assist with corrective action implementation.
  • Collaborate with production, engineering, QC, QA, laboratories, and technical development teams.

Your Profile:

  • Master's degree in Chemical Process Engineering, Biotechnology, or a related field.
  • Minimum 2 years of experience in a cGMP environment in the pharmaceutical industry.
  • Proven expertise in operating, qualifying, and validating pharmaceutical production equipment and systems.
  • Fluency in German and English (spoken and written).
  • Proficiency in tools such as MS Office, G Suite, Visio, and Lucid Chart.
  • Strong teamwork and stakeholder management skills.
  • A sense of urgency and ability to handle multiple priorities effectively.

? If this sounds like your profile, apply now to join this exciting project

Luciana Sardo

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