Location Measham and Clevedon (Multi-site role)
Purpose of Role
- To lead and manage the output of the Measham and Clevedon Production Units and associated activities so that customer service and productivity is measured and costs per unit output are minimized without any compromise to quality.
- To ensure that all relevant GMP and GDP related activities within the production units are completed to the required quality standard and any deviations are captured and investigated to the required standard.
- To liaise closely with Quality and Operational colleagues to deliver the agreed production schedule and coordinate the various elements required.
- Collaborate with QA on all matters relating to release of products so that service levels to customers can be managed appropriately.
- Active management of dynamic production schedules against variable customer demand
- Active maintenance, review and tracking of GMP & GDP procedures and documentation
- Development of the capacity of both sites such that current and planned production output can be achieved in a seamless way.
Skills & Experience (E: Essential; D: Desirable)
- At least 5 years’ management experience within manufacturing or operational environment either in the Pharmaceutical or Medical Device Industry (E)
- Ability to understand demand needs and planning such that production plans can be created and managed.
- Experience in providing strong and effective leadership in a multitask diverse manufacturing / operational teams (E)
- Demonstrable use of production related KPIs to measure and drive improvements in performance (E)
- Solid understanding of cGMP and cGDP (E)
- Understanding and application of Lean Manufacturing principles (D)
- Use of SAP (D)
To include some or all of the following:
- To provide professional leadership to the production units that ensures that we are operating to a best in class standard balancing both customers and internal efficiency targets in line with our business plans.
- To ensure that the production and storage of all finished goods manufactured by the Measham and Clevedon Units have been produced to GMP / MDD ISO13485 standards of quality following the approved operating procedures and documentation.
- To proactively review the SOPs covering cGMP and cGDP activities and maintain these to reflect current/ best working practices
- To ensure that all employees are trained on SOPs as required and relevant to their role and that this training is documented as SOPs are updated.
- To ensure qualification and maintenance of the Unit, its premises and equipment in line with GMP/MDD and that any changes (including equipment and facilities) are managed through the Quality change control process.
- Demonstrate effective and strong leadership while creating a culture of continuous improvement.
- Carry out active performance management of all team members
- Produce a monthly report detailing performance to plan, development and process improvement plans and staff effectiveness and efficiency data.
- Liaise with the Production Planner and NHS Customer Services team together with active management of the Production Unit resources to ensure all lead times are adhered to.
- Capture and collation of Production KPIs
- Lead the periodic production meetings to review performance against the issued production schedule and agree risks/ opportunities for recovering/ exceeding expected performance.
- Review and approve relevant GMP documentation including BMRs and process deviations, actively implementing root cause analysis, implementing and embedding corrective and preventative actions (CAPA) as appropriate.
- Actively participate in monthly Quality Review meetings.
- Create a production plan from the sales budget to ensure that resources are in place to run an efficient unit.
- Liaise with the medical devices commercial colleagues to ensure that we understand and deliver product to our distributors network as required.
- Liaise with the Medical Devices Product Development Group on the requirements for new product development and ensure that we have the capacity to respond to new requests.
Education & Training
- Min HND/ Degree qualified in a relevant discipline
Other Requirements (key competencies)
- Planning and organizing
- Delivery focus and ability to work under pressure
- Problem solving skills
- Communication and collaboration