QA Specialist, CSV & Automation m/f/d, Aargau
The QA Specialist, CSV & Automation plays a critical role in ensuring the quality, compliance, and lifecycle management of equipment and computerized systems supporting aseptic drug product manufacturing within CAPEX project portfolio.
Acting as a key Quality partner from project ideation through execution, this role safeguards adherence to GMP standards across all design and implementation phases. The QA Specialist provides oversight for qualification and validation activities, supports project teams with expert guidance, and ensures that systems, equipment, and infrastructure meet quality policies and regulatory expectations. Contract duration: 1 year
Location: Stein Responsibilities
* Oversee and ensure qualification and validation compliance for equipment, infrastructure, and computerized systems associated with aseptic drug product manufacturing and related utilities.
* Provide QA support for major CAPEX projects (e.g., new drug product facilities), ensuring quality requirements are embedded from concept through design and execution phases.
* Ensure that qualification/validation strategies, plans, and execution activities comply with quality policies and applicable regulations.
* Review and approve commissioning, qualification, and validation documentation, including SOPs, URS, FAT/SAT protocols, validation protocols, and final reports.
* Offer QA leadership and expert guidance to project teams on qualification, validation, and CSV topics across ongoing CAPEX initiatives.
* Ensure appropriate qualification of vendors and assessment of supplier-provided documentation.
* Serve as the primary Quality point of contact within GQE for all matters relating to equipment, infrastructure, and computerized-system lifecycle management and compliance.
* Ensure proper documentation and traceability within global quality systems (e.g., Kneat, TrackWise, DMS, Unifier).
* Manage Quality deviations, change controls, and CAPAs/tasks, ensuring timely resolution and escalation where appropriate.
Requirements
* Bachelor's or Master's degree in Engineering, Life Sciences, or a related scientific/technical discipline.
* Significant experience working within a GMP-regulated pharmaceutical environment, ideally within a Quality Unit.
* Demonstrated experience in a QA role focused on CSV and automation for GMP systems, particularly those supporting aseptic fill-finish operations (e.g., filling equipment, lyophilizers, clean utilities, cleanroom facilities).
* Strong understanding of qualification/validation requirements for equipment and computerized systems within a pharmaceutical manufacturing setting.
* Ability to influence project teams and provide clear, authoritative QA direction in a dynamic environment.
* Excellent communication skills in English; German language skills are an advantage.
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