QA Specialist (m/w/d)

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 cur rent 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