QA Specialist, CSV Automation

For our international pharma client we are looking for a
QA Specialist, CSV Automation (m/f/d).

Duration: 12 months (possibility of extension)

Workload: 100%

Location: Stein

Responsibilities

• Ensure qualification/validation plans and execution of equipment, infrastructure, and computerized systems in line with Quality policies.
• Approve SOPs, CQV/CSV protocols and reports including URS, FAT/SAT, and other project-related documentation.
• Provide QA leadership and oversight on qualification/validation topics for ongoing CAPEX projects.
• Support vendor qualification to ensure compliance with GMP standards.
• Act as first point of contact within GQE for lifecycle compliance of equipment, infrastructure, and computerized systems.
• Manage documentation in shared global systems such as Kneat, Trackwise, DMS, and Unifier.
• Handle quality deviations, changes, and CAPAs in a timely manner, taking leadersh...