Senior Quality Assurance Expert – Compliance, Drug Product Services
Lonza · Stein
Description du poste
About the role
Lead supplier qualification activities for GMP‑relevant materials, services and equipment across Basel and Stein, acting as the primary quality interface between Swiss and Indian sites.
Key responsibilities
- Manage qualification and lifecycle of GMP‑relevant suppliers, ensuring compliance with global quality standards and regulatory requirements.
- Review, approve and maintain supplier documentation, handling complex cases involving quality agreements, CAPAs, deviations and change requests.
- Represent Supplier Quality as a subject‑matter expert during customer audits and authority inspections.
Required profile
- Academic degree or vocational training in chemistry, biology, pharmaceutical sciences or related field.
- At least three years of experience in a GMP‑regulated pharmaceutical environment with strong quality and compliance knowledge.
- Experience in quality assurance or supply chain, preferably with supplier management and cross‑functional collaboration.
- Exposure to customer and regulatory audits (e.g., Swissmedic, FDA) is a strong advantage.
Required skills
- GMP compliance
- Supplier qualification
- CAPA management
- Quality agreements
- Audit participation (Swissmedic, FDA)
What we offer
- Agile career and dynamic work culture
- Inclusive and ethical workplace
- Competitive salary with performance‑based compensation programs
- Extensive lifestyle, family and leisure benefits
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Stein
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