| Location | Visp, Switzerland |
|---|---|
| Business Sector | Biotechnology |
| Contact name | Daria Finikova |
| Contact email | |
| Job ref | 24584 |
| Published | 9 days ago |
Location: Visp, Switzerland
Contract: Until end of the year
Languages: English (mandatory), German (a clear asset)
We are seeking a highly skilled and experienced professional to supervise compliance and customer Quality Agreement (QAA) activities for drug production. This role requires close collaboration with Drug Product Services (DPS) in Basel/Stein sites (e.g., Slough/Visp) to establish and negotiate Quality Agreements.
Establish, negotiate, and maintain Quality Agreements (QAA) in collaboration with DPS and DS sites.
Act as the primary point of contact for Drug Product QA-related inquiries, topics, and customer complaints.
Support and manage interactions in cases of changes, deviations, technical complaints, out-of-specification results, and other quality-related matters.
Represent Quality Assurance in cross-functional teams and maintain interfaces with Manufacturing, QC, Support Functions, Project and Site Engineering for effective task execution.
Serve as the QA representative in project teams and customer meetings during technical transfers.
Act as the QA contact for specific projects, ensuring regular follow-ups on DR and CR with customers.
Support and approve project/product-specific risk assessments, regulatory gap analyses, and risk evaluations.
Review and release product-specific documentation, including process descriptions, workflows, recipes, manufacturing protocols, transfer documents, test plans, and parameter lists.
Work closely with QC-Project Leaders (QC-PL) and MSAT for New Product Introductions (NPI).
Assess, review, and approve quality records such as deviations, change control, CAPAs, investigations, effectiveness checks, and extensions in compliance with local SOPs.
Author, review, and approve GMP-relevant documents and SOPs.
Support continuous improvement programs to enhance the Quality Management System for Drug Product.
Bachelor's or Master’s degree in Life Sciences, Pharmacy, or a related field.
5-10 years of relevant experience in Quality Assurance within drug production or pharmaceutical manufacturing.
Strong knowledge of GMP regulations and compliance requirements.
Experience in negotiating and managing Quality Agreements with external partners.
Ability to assess and resolve quality-related issues, including deviations, complaints, and investigations.
Proven ability to work cross-functionally with Manufacturing, QC, Engineering, and Regulatory teams.
Excellent communication and stakeholder management skills.
Proficiency in English is mandatory; German is a strong asset.