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Qa specialist, csv automation

Stein (Rheinfelden)
Hays
Inserat online seit: 23 Januar
Beschreibung

For our international pharma client we are looking for aQA Specialist, CSV Automation (m/f/d).Duration: 12 months (possibility of extension)Workload: 100%Location: SteinResponsibilitiesEnsure 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.RequirementsBachelor'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.

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