Huddersfield Pharmacy Specials (HPS) is an NHS hosted Specials manufacturing unit. Our mission is to provide high quality, affordable specials throughout the UK to both Primary and Secondary Care.
HPS manufactures a wide range of products including dermatological, oral, and topical liquids, infusion fluids and ampoules. We also provide a bespoke medicines packaging and labelling service. The facility has a MHRA Manufacturer (MIA) and “Specials” (MS) Licenses, a Wholesale Distribution Authorization (WDA(H)) and a Manufacturer License for Investigational Medicinal Products (Clinical Trials) (MIA(IMP)).
The post holder undertakes the preparation, filling and packaging of non-sterile medicines, together with a wide range of other activities to support the manufacturing section.
The work is carried out according to standard operating procedures designed to comply with the principles of current Good Manufacturing Practice (cGMP).
The work is mainly undertaken in a clean room environment
Undertakes the manufacture of a wide range of Non - Sterile Pharmaceutical Products in compliance with all local procedures and with the principles of current Good Manufacturing Practice (cGMP) which includes the following: .
Performing up to two garment change activities into specialised full body clean room garmentsPrepares, fills and/or repackages a wide range of non-sterile medicines and other products.
Views, inspects and labels manufactured products.
Uses, disassembles, cleans and re-assembles a variety of manufacturing and filling equipment.
Prints labels and assembles batch documentation for products manufactured.
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: -
- Undertakes the manufacture of a wide range of Non - Sterile Pharmaceutical Products in compliance with all local procedures and with the principles of current Good Manufacturing Practice (cGMP) which includes the following: .
- Performing up to two garment change activities into specialised full body clean room garments
- Prepares, fills and/or repackages a wide range of non-sterile medicines and other products.
- Views, inspects and labels manufactured products.
- Uses, disassembles, cleans and re-assembles a variety of manufacturing and filling equipment.
- Prints labels and assembles batch documentation for products manufactured.
- Accurately completes records for all activities on the appropriate documentation such as batch manufacturing records, cleaning logs, equipment logs, environmental monitoring forms etc
- Assists with the completion of corrective and preventive actions arising from QIRs and QERs within agreed time frames.
- Assists with remedial actions within the section arising from regulatory inspections (Medicines and Health Care Products Regulatory Agency [MHRA]), and from internal audits, within the specified time scales.
- Assembles and transports from the storage areas, components, raw materials and consumables required for the production process.
- Handles and moves goods and equipment (maximum weight 25kg), transferring them between cages, trolleys, cupboards and work areas and shelving that are at different levels.
- The role requires frequent light to moderate, long periods of physical effort with the occasional intense physical effort for short periods. This is typically in the cleanroom areas wearing restrictive garments.
- To assist with the training and demonstration of duties to new and existing HPS employees.
- Assists in the completion of corrective and preventative actions arising from quality investigation reports relating to the cleaning activities within agreed time frames.
- Performs specialised cleaning of the production area, or other pharmacy areas as necessary to cover sickness, leave and absence of specialised cleaning operatives.
- Removes rubbish, pharmaceutical, clinical and other waste materials to designated sites within the hospital.
- Transports manufactured batches to the finished goods store or bond store as appropriate, and ensures that the necessary documentation and/or samples are taken to Quality Control.
- Whilst performing duties is responsible for:
- following Trust Polices and HPS SOP’s
- liaising with Section Heads and prioritising work load around production
- reporting any damage or faulty equipment
- reporting any health and safety issues
- reporting to the Section Head any quality deviation found while carrying out their duties.
- complying with Health and Safety and COSHH regulations
- assisting with the maintenance of equipment to the required standards.
- maintaining appropriate stock levels and records.
- To participate in the Trust Appraisal Programme.
