QA PL Drug Product (6409)

Our client, a global leader in life sciences and biotechnology, is dedicated to advancing healthcare through high-quality products and cutting-edge innovations. Operating across multiple locations worldwide, they maintain the highest standards of compliance, efficiency, and customer satisfaction.

We are seeking a Quality Assurance PL (Drug Product) to oversee compliance and customer quality agreement (QAA) activities for Drug Product operations in Visp.

This is a contracting role until the end of 2025, with possibilities of extension.

This role involves close collaboration with Drug Product Services and Drug Substance sites. The ideal candidate will serve as a key point of contact for QA-related topics and customer interactions while ensuring the highest standards of compliance and product quality.

Key Responsibilities:

• Establish and negotiate Quality Agreements (QAA) with DPS and DS sites while overseeing compliance and customer QAA activities for Drug Product operations.
• Act as the primary QA contact for customer queries, complaints, and quality issues, managing related interactions such as changes, deviations, technical complaints, and OOS results.
• Represent QA in cross-functional teams, collaborating with Manufacturing, QC, Support Functions, and Engineering, while serving as the QA representative in project teams and customer meetings for technical transfers.
• Oversee project quality aspects, maintain customer communication on deviations and changes, and support risk assessments and regulatory gap analyses.
• Review and approve GMP-relevant documents, including protocols, workflows, test plans, deviations, CAPAs, and change controls, ensuring compliance with local SOPs.
• Work with QC-PL and MSAT teams for New Product Introductions (NPI) and drive continuous improvement of the Quality Management System for Drug Product operations.

Qualifications & Skills:

• Relevant working/residency permit or Swiss/EU-Citizenship required
• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Chemistry, or a related field.
• 5–10 years of experience in Quality Assurance within the pharmaceutical or biotechnology industry.
• Strong knowledge of GMP regulations and quality management systems.
• Experience in technical transfers and customer quality agreements.
• Fluency in English is mandatory; proficiency in German is a strong asset.

How to Apply: If you are interested in this exciting opportunity, please submit your application by clicking the 'apply now' button or sending your resume to: vanessa.gilardoni@ctcresourcing.com

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