Validation Support Officer | Calderdale and Huddersfield NHS Foundation Trust

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.

We employ more than 6,500 staff who deliver compassionate care from our two main hospitals, Calderdale Royal Hospital and Huddersfield Royal Infirmary as well as in community sites, health centres and in patients' homes. We also are incredibly proud to have almost 150 volunteers here at CHFT.

We provide a range of services including urgent and emergency care; medical; surgical; maternity; gynaecology; critical care; children's and young people's services; end of life care and outpatient and diagnostic imaging services.

We provide community health services, including sexual health services in Calderdale from Calderdale Royal and local health centres. These include Todmorden Health Centre and Broad Street Plaza.

We continue to modernise and invest in our health services to build on our strong reputation. Foundation trusts are public leaders in improving quality in health services. They are part of the NHS - yet decisions about what they do and how they do it are driven by independent boards. Boards listen to their Council of Governors and respond to the needs of their members - patients, staff and the local community.

Foundation trusts provide what the health service wants, yet are also free to invest quickly in the changes to the local community needs, in striving to be the best, and in putting their patients first.

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.

Disability Confident
About Disability Confident
A Disability Confident employer will generally offer an interview to any applicant that declares they have a disability and meets the minimum criteria for the job as defined by the employer. It is important to note that in certain recruitment situations such as high-volume, seasonal and high-peak times, the employer may wish to limit the overall numbers of interviews offered to both disabled people and non-disabled people. For more details please go to Disability Confident.