Validation Support Officer inHuddersfield inHuddersfield PUBLISHED 27 DEC 2023
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Validation and Qualification
Responsible for administration of the Validation Master Plan, including adding and archiving items where necessary
Assist in maintaining the qualification status of all equipment and working environments, in line with latest expectations.
Organising and assisting in the execution of revalidation and requalification.
Ongoing verification and routine monitoring of equipment where required
Liaises with potential equipment/service suppliers to ensure specifications are understood.
Liaises with the relevant HPS staff and CHFT/CHS procurement and finance staff as required.
Assist in Cleaning Validation activities.
Perform routine re-qualification of sterilisers (autoclaves and ovens).
Assist in the preparation and execution of validation and qualification protocols.
Prepares validation summary reports for validation and qualification activities.
Performs risk assessments (FMEA).
Prepares Standard Operating Procedures (SOPs) for the operation and maintenance of new equipment.
Trains staff in the use of new equipment.
Coordinates external contractors performing qualification activities.
Assists in identifying the maintenance and calibration requirements of equipment, setting up maintenance contracts and coordinating maintenance and calibration activities.
Routine responsibility for the Building Management System (BMS)
Routine responsibility for the Asset Management System covering equipment, utilities and facilities.
All PTW paperwork is completed and up to date with relevant approvals
On-call person as part of the rota for site relating to out-of-hours cover
Projects
Lead minor equipment/facilities projects linked to CAPEX using established Project Management systems, including planning, organisation, oversight, tracking, communication and execution.
Assist in the generation of URS
Review and approval of supplier
Provide support for other projects in the Unit
Quality and Compliance
Ensure all validation and qualification activities are carried out in accordance with the principles of cGxPs (especially Annex 15) in order that the quality and compliance requirements are met.
Operate within the Quality Management System including:
o Change Control
o Deviations and investigations
o CAPAs
Assist in review, update and implementation, of relevant SOPs, ensuring compliance with latest regulatory expectations.
Follow defined SOPs relating to all aspects of work
Maintain accurate records aligned with ALCOA+ principles
Participate in inspections and audits as required
Ensures that the data integrity requirements for GMP are complied with during all aspects of work
Health, Safety and Environment
Ensures that Health and Safety and COSHH regulations relating to validation and qualification activities are adhered to.
Manual Handling of equipment, parts and materials is done in accordance with good practice.
Continuous Improvement
Identify and implement continuous improvement of systems, processes and equipment, taking into account advances in technology and best practice. Note continuous improvement could be related to quality, efficiency, customer satisfaction, culture or cost.
The purpose of this role is to support the facility to ensure the premises and equipment are suitably maintained in a qualified state in compliance with cGxPs.
The main duties will primarily focussing on the re-qualification and re-validation of current infrastructure, including utilities, equipment, and processes.
The role will include small project work relating to changes within the unit and aligned with business continuity, continuous improvement, and growth strategy. It will also include supporting larger project work as part of the Validation Team.
Validation and Qualification
Responsible for administration of the Validation Master Plan, including adding and archiving items where necessary
Assist in maintaining the qualification status of all equipment and working environments, in line with latest expectations.
Organising and assisting in the execution of revalidation and requalification.
Ongoing verification and routine monitoring of equipment where required
Liaises with potential equipment/service suppliers to ensure specifications are understood.
Liaises with the relevant HPS staff and CHFT/CHS procurement and finance staff as required.
Assist in Cleaning Validation activities.
Perform routine re-qualification of sterilisers (autoclaves and ovens).
Assist in the preparation and execution of validation and qualification protocols.
Prepares validation summary reports for validation and qualification activities.
Performs risk assessments (FMEA).
Prepares Standard Operating Procedures (SOPs) for the operation and maintenance of new equipment.
Trains staff in the use of new equipment.
Coordinates external contractors performing qualification activities.
Assists in identifying the maintenance and calibration requirements of equipment, setting up maintenance contracts and coordinating maintenance and calibration activities.
Routine responsibility for the Building Management System (BMS)
Routine responsibility for the Asset Management System covering equipment, utilities and facilities.
All PTW paperwork is completed and up to date with relevant approvals
On-call person as part of the rota for site relating to out-of-hours cover
Projects
Lead minor equipment/facilities projects linked to CAPEX using established Project Management systems, including planning, organisation, oversight, tracking, communication and execution.
Assist in the generation of URS
Review and approval of supplier
Provide support for other projects in the Unit
Quality and Compliance
Ensure all validation and qualification activities are carried out in accordance with the principles of cGxPs (especially Annex 15) in order that the quality and compliance requirements are met.
Operate within the Quality Management System including:
o Change Control
o Deviations and investigations
o CAPAs
Assist in review, update and implementation, of relevant SOPs, ensuring compliance with latest regulatory expectations.
Follow defined SOPs relating to all aspects of work
Maintain accurate records aligned with ALCOA+ principles
Participate in inspections and audits as required
Ensures that the data integrity requirements for GMP are complied with during all aspects of work
Health, Safety and Environment
Ensures that Health and Safety and COSHH regulations relating to validation and qualification activities are adhered to.
Manual Handling of equipment, parts and materials is done in accordance with good practice.
Continuous Improvement
Identify and implement continuous improvement of systems, processes and equipment, taking into account advances in technology and best practice. Note continuous improvement could be related to quality, efficiency, customer satisfaction, culture or cost.
The purpose of this role is to support the facility to ensure the premises and equipment are suitably maintained in a qualified state in compliance with cGxPs.
The main duties will primarily focussing on the re-qualification and re-validation of current infrastructure, including utilities, equipment, and processes.
The role will include small project work relating to changes within the unit and aligned with business continuity, continuous improvement, and growth strategy. It will also include supporting larger project work as part of the Validation Team.
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