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QA Specialist, CSV Automation

vor 2 Wochen

Stein, Aargau, Schweiz Hays Vollzeit

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.