C&Q Area Lead

4 weeks ago

Dublin, Ireland Quanta Consultancy Services Ltd Full time

Overview
C&Q Area Lead - HVAC/Cleanrooms- South Dublin - 12 Month Contract.
Our client, a globally recognised pioneer in Biotechnology, is recruiting for the position of C&Q Area Lead- HVAC/Cleanrooms.
A leader in the industry, our client focuses on areas of high unmet medical need and leverages its expertise to strive for solutions.
This is your chance to join them on their global mission to better the lives of those affected by disease and illness.
Responsibilities
Lead the planning, execution, and documentation of C&Q activities for the assigned area, including equipment, utilities, facilities, and processes.
Develop and maintain area-specific C&Q plans, test strategies, and supporting documentation.
Coordinate 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.
Requirements
Bachelor's or Master's degree in Engineering, Life Sciences, or a related field.
Requires extensive 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.
If this role is of interest, please apply now
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