Qualification and Validation Manager
vor 2 Wochen
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
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