Job Responsibilities:
Generation of qualification risk assessment/testing matrix for qualification protocols and supporting documents in line with User Requirements/Equipment Specifications/ MSD and cGMP compliance standards.
Preparation and approval of Utilities Validation SOPs
Preparation and approval of Validation test equipment SOP's
Management of Validation Test equipment with support from site maintenance management team. (Calibration/System Maintenance and Calibration Event handling)
Qualification of Validation test equipment.
Develop, review and execute GMP critical utility Performance Qualification (PQ) protocols and PQ reports for GMP Critical systems e.g. HVAC, RO/PW/WFI, Clean Steam, Clean Compressed Gasses, walk in cold storage.
Equipment/System assessments for 'Computer System Qualification' requirements and 'Execution of Electronic Records and Electronic Signatures' requirements.
Identify, document and track validation events
Full oversite of all personnel and contractors participating or executing PQ activities, ensuring all team members are trained and follow the relevant site procedures.
Responsible for ensuring documentation being leveraged for PQ testing from project commissioning phase/IQ/OQ are referenced as per associated qualification, referencing procedures.
Responsible for validation tasks/actions associated with quality system change controls and investigations where required.
Development/Generation of Utilities Validation Master Plan.
Periodic review and revalidation assessment.
Education/Experience:
Minimum qualification BSc or MSc/M.Eng Degree in Engineering or equivalent discipline.
Must have excellent verbal and written communication skills. Having a minimum of 5 years
in an Engineering CQV role with extensive cGMP experience in Commissioning Qualification & Validation, ideally covering GMP Critical Utilities Equipment Engineering.
Have good understanding of Instrumentation/Calibration, Utilities Equipment incl. HVAC, WFI/RO/PW, Clean Steam Gases, Refrigeration Systems.
In depth knowledge and experience with validation test equipment/systems. A good understanding of associated Maintenance/Calibration requirements of such systems is also a requirement.
Have the capability and experience to manage Vendors and Contractors supporting PQ activities.
Ability to work independently and as part of a team in a cross functional collaborative environment.
If you would like to hear a little bit more about it, please email me your CV to [email protected] or apply in the link below.
