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QA Specialist
Tasks:
- Represent Quality Assurance in project teams and participate actively in cross‑functional meetings to ensure quality considerations are integrated into all project phases.
- Serve as the primary QA contact for designated topics, including the coordination and oversight of DRs and CRs.
- Act as the point of contact for Drug Product QA matters, addressing customer inquiries, operational questions, and complaints related to manufacturing activities.
- Support, evaluate, and approve risk assessments, including regulatory‑driven risk or gap analyses.
- Review and release product‑specific documentation such as process descriptions, workflows, recipes, manufacturing protocols, transfer documents, test plans, and parameter lists.
- Represent Drug Product QA during regulatory inspections and contribute to inspection readiness activities.
- Drive and support continuous improvement initiatives aimed at strengthening the Quality Management System at Visp DPS.
- Collaborate closely with Manufacturing, QC, Support Functions, and Engineering teams to ensure seamless execution of Drug Product processes and technology transfers.
- Assess, review, and approve quality records and release documentation (e.g., deviations, change controls, CAPAs, investigations, effectiveness checks, complaints, APR/PQRs) in accordance with current SOPs and GMP requirements.
Qualification:
University degree in Chemistry, Biology, Biotechnology, or a related scientific discipline.
Extensive experience working in a GMP‑regulated pharmaceutical environment.
Proven background in Quality Assurance within Drug Product operations.
Strong understanding of pharmaceutical manufacturing processes, quality systems, and regulatory expectations.
Excellent communication and stakeholder‑management skills, with the ability to collaborate effectively across functions.
Fluency in English; German language skills are considered an advantage.
Strong organizational skills and the ability to manage priorities in a dynamic environment.
Requirements:
Start: 02.02.2026
Duration: 6 months
Capacity: 5 days per week
Location: Visp, Switzerland
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