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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