Headcount Solutions is seeking a Commissioning and Qualification (C&Q) lead for a large-scale Fill Finish Project in the Pharmaceutical Industry. This person will lead a team of C&Q engineers to ensure the C&Q activities associated with a large fill finish project are completed safely, as per schedule and in compliance with GMP and Quality Requirements.
· Coordinate and Supervise all C&Q activities.
· Approve C&Q planning documents detailing overall strategy for the project.
· Develop and approve the master list of C&Q test documents and activities.
· Review and approve all C&Q summary reports.
· Ensure the C&Q schedule is developed and maintained.
· Ensure all C&Q Engineers who perform C&Q activities have relevant training assigned.
· Pre-approval and post-approval of C&Q test documents.
· Manage daily C&Q coordination meetings.
· Responsible for overall tracking and reporting of C&Q status and risks/issues.
· Ensure start-up of equipment/utilities is completed in a safe and coordinated manner.
· Assist in the development of User Requirement Specifications (URS’s) and Quality Risk
Assessment for Equipment and Automated Systems (QRAES)
· 6+ years’ experience in Engineering or Commissioning and Qualification Management
· Technical qualification at third level or equivalent in Engineering.
· Extensive knowledge and demonstrated experience managing Commissioning and Qualification for Pharmaceutical / Biotechnology projects.
· Experience of sterile / biotech equipment within the pharmaceutical industry is preferred.
· Knowledge of safety, GMP and environmental regulatory requirements.
· Demonstrated strong communication and leadership skills.
· Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes.
· Strong understanding of a risk-based approach to commissioning and qualification within the biotechnology industry.