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Qa Manager Clinical Gcp Audits And Compliance
vor 3 Monaten
12 months Contractor role in Zurich
Our customer is a research and development driven biopharmaceutical company based in Zurich, focusing on Immune Response diseases. They are pioneering the development of innovative MAbs and collaborating with major pharmaceutical companies in clinical trials.
For additional support in the expanding Quality Assurance activities, we are in need of an experienced QA professional with expertise in GCP audit procedures.
This role is initially temporary with a high likelihood of transitioning into a permanent position later this year.
We are searching for an independent, skilled professional who can effectively oversee and manage QA responsibilities related to GXP, including coordinating internal training, handling projects, and supporting cross-functional teams.
Physical presence on-site for up to 4 days per week is mandatory.
Your tasks:
- Oversight for QMS Quality Management System
- Quality supervision before, during, and after clinical trials
- Leadership in GCP/GMP/GLP Vendor Qualifications
- Organizing and conducting audits at GCP/GMP vendors
- Coordinating internal audits and regulatory inspections
Your profile:
- B.Sc, M.Sc in Life Sciences
- 3-5 years of experience in Clinical QA Operations
- Background in CRO and Clinical Vendor Management
- Solid understanding of GCP and GMP regulations
Your independence, integrity, and proactiveness are highly valued. Your customer-focused approach will facilitate communication with all stakeholders, both internal and external. Become a valuable addition to our customer's team in this collaborative work environment. The office is conveniently located near public transportation in the Zurich area.