Production Technical Specialist Corsham, England
Job description
About us
Award-winning pharmaceutical group based in Corsham, Wiltshire.
The Pharmaxo group operates within the pharmaceutical aseptic compounding, clinical homecare and laboratory services sectors. Through our scientific research and technology capabilities, the team continues to develop innovative methods to improve our products and services. We are located in a new, multimillion pound manufacturing and office facility in Corsham Science Park in Wiltshire, just 5 miles from Chippenham and 8 miles from Bath. The Pharmaxo Group comprises of:
Bath ASU produces around 2,000 aseptically compounded injectable pharmaceutical products each day for hospitals and patients across the UK who are fighting cancer, living with chronic disease or in need of pain relief.
Pharmaxo Healthcare is a growing clinical homecare provider in an expanding market offering greater convenience to patients whilst delivering efficiencies to the NHS.
Pharmaxo Scientific holds and develops intellectual property, which is currently licensed to the groups other operating subsidiaries.
Your role
You will be a change agent and a pivotal part of ensuring we refine and continuously improve manufacturing processes to ensure we are as efficient as possible. You will have a focus on equipment and facilities, identifying automation opportunities, introduction of new equipment, equipment qualification, ensuring compliance with preventative maintenance and qualification through its lifecycle. You will understand GMP and work within those parameters to ensure manufacturing remains compliant. You will add weight to the culture change from a reactive way of working to a proactive continuous improvement mentality, always striving to make processes better. This is an exciting and critical role in a fast expanding business.
Your duties & responsibilities
- To assist with coordination of eMaint and preventative maintenance tasks, ensuring all validations are kept up to date and audit ready.
- To keep an up-to-date asset register and equipment life cycle sheet to assist with Capex budgeting.
- To work with the engineering team to ensure all required documentation is completed for planed maintenance activities, activities are completed following current GMP practices.
- To coordinate and facilitate the deep cleaning schedule for all units.
- To look for automation opportunities, ensuring all new equipment completes required qualifications.
- A change agent who can analyze data, conduct RCA and then generate an action plan and execute that plan to completion.
- Have reactive problem-solving skills to fix immediate issues when required
- Review trends in deviations and QERs to take a more proactive approach to problem solving.
- Use Lean tools to enhance the production environment and coach the team to work smarter not harder
- Assessment of all manufacturing processes to ensure poka-yoke is applied.
- Initiate and revise Production documentation (SOPs) to ensure that Best Practice is employed, and that documentation is an accurate reflection of the process.
- Monitor, report on and reduce the 7 wastes within Production.
- The investigation and resolution of Production events including the introduction and monitoring of CAPA effectiveness.
- Drive improvements via the Change Control System by continuous monitoring of Compliance and throughput.
- To assist with the generation and delivery of Production training materials. Specifically, when new ways of working are introduced.
- To assist with quality improvement activities within the Quality Management System
- Undertake or assist with investigative environmental monitoring including temperature, pressure, particulate and microbiological contamination. To report (on relevant form) any results which are outside the stated limits and participate in the immediate corrective actions, causes and preventative measures.
- To be a lean champion and coach the team in all things lean.
- To deputize for the Production Compliance & Training Manager as required.
- To ensure that the relevant principles of (GMP) are applied at all times
- To ensure compliance with the Health and Safety at Work Act and all other relevant legislation e.g. Medicines Act, Control of Substances Hazardous to Health (COSHH)
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Commitment to participate in any overtime, extended hours and Bank Holidays rotas when required.
- Completion of the NCFE Level 2 Intermediate Award in Aseptic Services as part of your induction.
- To undertake any other duties as required by the Production Management Team.
- To be a member of the out of hours on-call team on a rotad basis, covering approx 4 weeks a year.
The skills & attributes you will bring
- You will have an equipment/engineering bias.
- You will have knowledge of equipment qualification.
- You will have a good understanding of Lean principles and experience in leading Kaizen events.
- You will have a track record of delivering continuous improvements.
- You will have a good understanding of GMP
- You will have experience in a process engineering/efficiency role in the past with demonstratable improved results
- You will be a team player
- You will be a great communicator
Review
This job description is not intended to be exhaustive. The post holder will be required to be flexible and take on projects and responsibilities as the company grows.
Benefits
- Salary: £32,000 - £40,000 per annum
- 29 days holiday (including bank holidays). This is increased by 1 day after 1 year of continuous employment, up to a maximum of 5 days.
- Company bonus scheme
- Pension - you will be auto-enrolled after 3 months of employment at 5%. You can opt to contribute 6% to which the employer will contribute 8%.
- Life assurance 8 x salary with a max of £200,000
- 6 month probation period
