Commissioning and Qualification Lead – REF 02021MQ

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.

Key Responsibilities:

 

·            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)

 

Requirements:

·            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.

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