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 leadership for resolution and escalating when necessary.
Requirements
* Bachelor's or Master's degree in Engineering, Life Sciences, or a related field.
* Significant experience in GMP-regulated pharmaceutical industry, preferably within a Quality Unit.
* Proven QA experience in CSV/Automation for GMP systems related to aseptic fill-finish processes.
* Knowledge of aseptic facility equipment including filling equipment, lyophilization, clean utilities, and clean room facilities.
* Fluency in English; German language skills are an advantage.