Commissioning & Qualification Lead
- Dublin
- Contract
- Full-time
- Lead the planning, execution, and documentation of C&Q activities for the designated [AREA], including equipment, utilities, facilities, and processes.
- Develop and maintain area-specific C&Q plans, test strategies, and support documentation.
- Collaborate with cross-functional teams (Engineering, Operations, Quality, Contractors) to ensure timely and compliant execution of C&Q deliverables.
- Provide subject matter expertise on pharmaceutical standards (e.g., GAMP, ISPE, ICH) and regulatory expectations (e.g., FDA, EMA).
- Review, approve, and ensure completeness of C&Q documentation, including protocols, risk assessments, and summary reports.
- Track and resolve discrepancies, deviations, and change controls related to C&Q activities.
- Drive continuous improvement initiatives to enhance C&Q processes and reduce project risk.
- Bachelor's or Master's degree in Engineering, Life Sciences, or a related field.
- 5-10+ years of experience in Commissioning & Qualification within a GMP-regulated environment, preferably in the pharmaceutical or biopharmaceutical sector.
- Proven leadership experience managing C&Q teams or specific project areas.
- Strong technical knowledge of commissioning, qualification, and validation practices.
- Deep understanding of regulatory guidelines and industry best practices (FDA, EMA, ICH, ISPE, GAMP).
- Experience with digital validation tools (e.g., Kneat, EDMS).
- Excellent communication, leadership, and interpersonal skills.
- Strong analytical and problem-solving abilities.
- Ability to manage multiple priorities in a fast-paced, dynamic environment.