Safeguard quality, shape compliance, and power the future of aseptic manufacturing.
Join one of Proclinical's clients as a Quality Assurance Specialist and help safeguard the integrity of aseptic manufacturing. In this role, you'll drive compliance for equipment and computerized systems, ensuring GMP processes meet the highest standards. As part of major CAPEX initiatives, you'll lead commissioning, assessment, and verification efforts while facilitating adherence to quality and regulatory frameworks.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
Responsibilities:
1. Ensure compliance of commissioning and qualification activities for large CAPEX projects, including new drug product facilities.
2. Develop and oversee qualification and validation plans for equipment, infrastructure, and computerized systems.
3. Approve SOPs, commissioning/qualification/validation protocols, and project-related CQV-CSV documents (e.g., URS, FAT, SAT).
4. Provide QA leadership and guidance on qualification and validation topics for ongoing projects.
5. Act as the primary QA contact for lifecycle and compliance matters related to equipment, infrastructure, and computerized systems.
6. Manage documentation in shared global systems such as Kneat, Trackwise, DMS, and Unifier.
7. Address quality deviations, changes, and CAPAs in a timely manner, escalating issues when necessary.
Key Skills and Requirements:
8. Academic background in Engineering, Life Sciences, or a related field.
9. Experience in a GMP-regulated pharmaceutical environment, preferably within a Quality Unit.
10. Expertise in QA for CSV and automation of GMP systems, particularly in aseptic fill-finish processes, facility filling equipment, lyophilization, clean utilities, and clean room facilities.
11. Proficiency in English; German language skills are advantageous.