IT Compliance Expert for Pharmaceutical Industry
Vor 7 Tagen
Gloor & Lang AG is seeking an experienced professional to support the implementation of new IT systems at our client's manufacturing and packaging units. The successful candidate will have expertise in Computer System Validation (CSV) and Quality Management Systems.
Key responsibilities include ensuring compliance with pharmaceutical industry standards and regulations, leading CSV activities, and overseeing the qualification of site IT infrastructure. Additionally, the candidate will translate compliance requirements into test conditions and acceptance criteria for application functionality.
The ideal candidate will have a Bachelor's degree in Science, Engineering, or a related discipline, along with 7-10 years of experience in the pharmaceutical or biotechnology industry. Strong analytical and structured working style, excellent communication and collaboration skills, and proficiency in English and French are required. Swiss residency or a valid work permit is mandatory.
We offer a competitive salary of approximately CHF 90,000 - 110,000 per year, depending on experience, and a collaborative work environment with opportunities for professional growth. If you are a motivated and detail-oriented professional looking to make a meaningful contribution, please submit your application.
Responsibilities:
- Ensure compliance with EU-GMP Annex 11 and 21-CFR part 11
- Lead Computer System Validation (CSV) activities
- Act as local representative for global IT projects
- Oversee qualification of site IT infrastructure
- Define quality expectations and support implementation of GMP-compliant systems
- Conduct risk-based prioritization of IT activities
- Translate compliance requirements into test conditions and acceptance criteria
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