Join a multi-functional utilities team and be responsible for the
qualification, validation maintenance and periodic review of
activities associated with GMP Critical Utility equipment and systems
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&#**Apply
on the website**;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 &#**Apply on the website**;Computer
System Qualification&#**Apply on the website**; requirements and
&#**Apply on the website**;Execution of Electronic Records and
Electronic Signatures&#**Apply on the website**; 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.
* 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 Pharmaceutical
Join a multi-functional utilities team and be responsible for the
qualification, validation maintenance and periodic review of
activities associated with GMP Critical Utility equipment and systems
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&#**Apply
on the website**;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 &#**Apply on the website**;Computer
System Qualification&#**Apply on the website**; requirements and
&#**Apply on the website**;Execution of Electronic Records and
Electronic Signatures&#**Apply on the website**; 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.
* 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
We need : English (Good)
Type: Permanent
Payment:
Category: Others
