Headcount Solutions Limited

Commissioning and Qualification Lead (BB-7CFE7)

Found in: Neuvoo IE

Description:
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 RiskAssessment 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.For further information please contact Mick on (phone number removed) or forward details in confidence to

calendar_today6 days ago

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location_onDublin, Ireland

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