The purpose of this role is to provide a support service to the Division by ensuring the site is maintained in compliance with cGxPs, safe and secure. This includes aspects of infrastructure, facilities, utilities, and processes critical to the compliant and efficient operations of the Division.
This is a matrix role which requires the post holder to work closely with other stakeholders outside the Division to remain compliant with TRUST polices regarding facilities, security, HS&E and waste management.
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Primarily reporting to the Head of Production, the post holder will be expected to work autonomously to:
- Line Manage the HPS Domestic / Specialist Cleaning Team.
- Be the Division’s “go to” for the site’s infrastructure, facilities and utilities.
- Maintain Divisional Health, Safety and Environment compliance.
- Work alongside and support the site Validation Lead to ensure cGXP compliance.
- Professionally engage and be the key point of contact with:
- THIS (IT Infrastructure)
- CHS Estates Team
- CHS Procurement Team (Building / Equipment matters)
- CHFT H&S
- External Contractors
You will be expected to use judgement based on facts and analysis to coordinate and plan the Trusts support departments to ensure that the needs of the Division are met supporting the efficient and continuous supply of medicines to patents nationally.
The HPS Domestic / Specialist Cleaning Team provide specialist cleaning of Grade D and C cleanrooms, general cleaning duties of shared communal areas / corridors as well as warehousing, offices and laboratory.
CHFT is an integrated acute and community Trust serving diverse communities across Calderdale and Kirklees, with strong partnerships across West Yorkshire. We are proud of our One Culture of Care — caring for each other with the same compassion, kindness and respect that we show our patients — and of the values that underpin how we work: we put people first, we go see, we work together to get results, and we do the must dos.
CHFT is recognised as a forward looking, digitally enabled Trust, with a strong track record of using data, innovation and system collaboration to improve quality, safety and outcomes. We are ambitious about the role that acute trusts play in prevention, population health and reducing inequalities, and this post sits at the heart of that agenda.
The postholder: -
Facilities and Equipment
- Responsible for maintaining assets across site covering equipment, utilities, and facilities.
- Organises, coordinates and ensures the complex annual shutdowns are completed.
- Overseas contractor activities on site regarding to facilities and associated equipment.
- Responsible for maintaining details in the Asset Management System ensuring all records and documents are logged and stored.
- Organises and ensures all plant equipment, facilities and fabric are maintained and where applicable aligned with the validation master plan as defined by the HPS Validation Lead.
- Organise insurance inspections as required.
- Management of contractors and the site Passport / Permit to Work process relating to equipment, utilities, and facilities.
- Perform improvement works on facilities.
- Liaise and coordinate CHS Estates for all Estates organised visits.
- Administration of Service Level Agreements (SLA) for facility wide equipment.
- Liaises with CHS Procurement and the HPS Validation Lead for the renewal and specification for all service level agreements for plant.
- Responsible for daily checks within the facility.
- Responsible for all logging and trending of data collected for facility wide equipment outside of validation oversight.
- Perform problem solving, fault finding and remediation where required, including on specialist equipment.
- Specific ownership of key critical equipment requiring in-depth expertise, e.g. WFI plant and HVAC.
- Oversight and development of policies / procedures for site security including CCTV system.
- Member of the On-call team partaking in out-of-hours cover.
- Ensure facilities cleaning activities are performed according to validated processes.
- Expected to work within the clean area.
- Develop a Divisional facilities meeting, including safety, waste and security topics.
- Responsible for reducing the amount of production downtime due to equipment breakdowns and facility upgrade / repairs.
- Reviews and develops policies / SOPs for maintenance, safety, cleaning and security across the division.
- Works with Trust Stakeholders to review their policies so they support and reflect the legislative requirements of the Division.
- Development of URS in relation to the procurement of equipment and building repairs / upgrades.
Health, Safety and Environment
- Support the Division in developing and maintaining Process Risk Assessments.
- Coordinate with the Trust Lead and be the Divisions “go to” for Health, Safety and Environment.
- Coordinate with the Trust Lead and be the Divisions “go to” for Fire Safety.
- Coordinate with the Trust Lead and be the Divisions “go to” for Waste Management.
- Ensures that Health and Safety and COSHH regulations relating to facilities are adhered to.
- Manual Handling of equipment, parts and materials is done in accordance with good practice.
- Fire warden responsibilities.
Projects
- Lead major equipment/facilities projects linked to CAPEX using established Project Management systems, including planning, organisation, oversight, tracking, communication, execution, and handover.
- Provide support for other projects in the Division as Subject Matter Expert
Quality and Compliance
- Ensure all maintenance activities are carried out in accordance with the principles of cGxPs 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
- Owner of relevant SOPs and responsible for their accuracy, review, update, and implementation, 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 Subject Matter Expert
- Ensures that the data integrity requirements for cGMP are complied with during all aspects of work.
Continuous Improvement
- Identify and implement continuous improvement of systems, processes, and equipment, considering advances in technology and best practice. Note continuous improvement could be related to quality, efficiency, customer satisfaction, culture, or cost.
Clinical Duties
- This role is deemed to provide a basic clinical technical service indirectly to patients in the manufacturing and delivery of medicines.
Professional Duties
- Maintain a working competence in all areas of responsibility and to exercise the knowledge and skill that can be reasonably expected based on the role and any relevant qualifications.
- Operate professionally and impartially.
- Declare and avoid any potential conflicts of interest created by the post.
Managerial Duties
- Direct line manager responsibilities for the domestic / specialist cleaning team including:
o Holiday approval and oversight
o Appraisals and Personal Development
o Absence and performance management
o Training and competency
- Direction and prioritisation of workload for the team.
- Recruitment of team members.
- Monitor and report relevant KPIs, ensuring targets are being achieved and implementing remedial actions where necessary.
- Write business cases and reports for the Senior Leadership Team to make informed business decisions regarding procurement, investment and organisational / operational structure.
Financial Duties
- Responsible for the repair and maintenance of general equipment and systems.
- Contribute towards the preparation of the Divisional budget.
Managing Self
- As a “go to” support services role work patterns are expected to be unpredictable and subject to frequent interruptions from internal and external stakeholders.
- Participate in regular supervision.
- Attend all mandatory training.
- Participate in appraisal at least annually identifying, developing, and agreeing your own development plan with your Line Manager using the Trust Appraisal.
- Comply with all Trust policies, procedures, and protocols.
- Carry out duties with due regard to the Trust’s Equal Opportunity Policy.
- Seek advice and support from Line Manager whenever necessary.
- Maintain professional conduct always including appearance.
- Exhibit the values and behaviours expected by the Trust as part of “One Culture of Care”
This job description is an outline only and is not definitive or restrictive in any way. It will be regularly reviewed and may be amended in the light of changing circumstances following consultation with the post holder.
