Job Description:
We are seeking a Quality Assurance PL (Drug Product) to oversee compliance and customer quality agreement activities for Drug Product operations in Visp.
This is a contracting role until the end of 2025, with possibilities of extension.
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:
* Rlevant 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.