QA Specialist

For one of our clients based in Stein (Aargau), we are currently looking for a QA Specialist that would be responsible for the qualification and validation compliance of equipment and computerized systems. Ideally someone who has experience in a QA role for the CSV / Automation of GMP systems related to aseptic fill-finish processes and facility.

Key Responsibilities:

• Oversee compliance for commissioning and qualification of large CAPEX projects (e.g., new drug product facilities) from ideation through execution.
• Approve SOPs, commissioning/qualification/validation protocols, reports, and project-related CQV/CSV documents (e.g., URS, FAT/SAT).
• Provide QA leadership, oversight, and support on qualification/validation topics for ongoing projects, ensuring vendor qualification.
• Serve as the primary contact within GQE for lifecycle and compliance matters related to equipment, infrastructure, and computerized systems qualification/validation, including documentation in global systems (e.g., Kneat, Trackwise, DMS, Unifier).
• Manage quality deviations, changes, and CAPAs/tasks promptly, taking leadership for resolution and escalating when necessary.

Key Requirements:

• Bachelor’s or Master’s degree in Engineering, Life Sciences, or a related field.
• Significant experience in the GMP-regulated pharmaceutical industry, preferably within a Quality Unit.
• Experience in a QA role for CSV/Automation of GMP systems related to aseptic fill-finish processes and facilities (e.g., filling equipment, lyophilization, clean utilities, clean room facilities).
• Fluency in English; German proficiency is an advantage.

Job Title: QA Specialist

Location: Stein, Switzerland

Job Type: Contract

If you feel confident about this opportunity, we encourage you to apply, or to reach out to me via email at mbertrand@actalentservices.com.