Project Manager for Commissioning and Qualification
Are you a seasoned professional with experience in managing complex projects and teams? Do you have a strong understanding of regulatory requirements and industry best practices? We are seeking a highly experienced Project Manager to lead and coordinate commissioning and qualification activities across various projects.
* Lead and coordinate the CQV execution team, ensuring timely execution and compliance with SOPs and current industry regulations.
* Support and coordinate the transition to a digitized C&Q platform (Kneat Solutions).
* Ensure effective resource planning is established and managed throughout the project.
* Manage and coordinate equipment qualification activities, including FAT, SAT, Design Qualification, IQ, OQ, and PQ.
* Develop and maintain project plans, schedules, and budgets to ensure alignment with business objectives.
* Identify and mitigate project risks while ensuring project deliverables meet required quality and compliance standards.
To be successful in this role, you will need:
* A relevant qualification (Degree) and/or relevant experience of 10+ years in the biotech/pharmaceutical industry qualifying GXP systems.
* A minimum of 5 years' experience in a lead CQV role with responsibility for managing a commissioning and qualification team.
* Experience of managing teams or projects in a fast-paced and complex environment.
* A clear understanding and previous experience in deployment and execution of a RBV (Risk-Based Validation) process in line with ISPE guidelines.
* Excellent verbal and written communication skills, as well as experience in developing strong working relationships with other departments.
If you have the necessary skills and experience, please apply now to take your career to the next level.