QA Specialist

Summary: The QA Specialist role involves acting as a representative for Quality Assurance in project teams and meetings, addressing Drug Product QA inquiries, and supporting regulatory compliance. The position requires reviewing and approving quality documentation, participating in inspections, and contributing to continuous improvement initiatives within the Quality Management System. The role is based in Visp, Switzerland, and requires a strong background in the pharmaceutical industry, particularly in GMP environments.

Key Responsibilities:

• Act as QA representative in Project teams and represent QA in meetings
• Act as QA contact for specific topics and realize the interface for DRs and CRs
• Act as point of contact for Drug Product QA related questions, topics and complaints from customers related to the manufacturing operations
• Support and approve risk assessments or regulatory specific risk or gap assessments.
• Review and release product specific documentation such as process descriptions and workflows, recipes, manufacturing protocols, transfer documents, test plans, parameter lists, etc.
• Represent Drug Product QA topics during regulatory inspections.
• Support continuous improvement programs to establish an effective Quality Management System for Visp DPS.
• Represent Quality Assurance in cross-functional teams, establish and maintain interfaces with the Manufacturing teams, QC, Support Functions, Project- and Site Engineering project / technology transfer to effectively execute tasks related to Drug Product processes.
• Assess, review and approve quality records and release files/dossiers e.g. deviations, change control, CAPAs, investigations, effectiveness checks, extensions, complaints, APR/PQRs, in line with current local SOPs.

Key Skills:

• University degree or equivalent in Chemistry / Biology / Biotechnology or a related field
• Long-term experience working in the GMP environment of the pharmaceutical industry
• Experience working in a QA department Drug Product
• English language skills are required, German language is an advantage

Salary (Rate): undetermined

City: Visp

Country: Switzerland

Working Arrangements: undetermined

IR35 Status: undetermined

Seniority Level: undetermined

Industry: Other