Quality Control Team Leader
Bath ASU (part of the Pharmaxo Group) produces over 3,000 aseptically compounded injectable pharmaceutical products each day to hospitals and patients across the UK who are fighting cancer, living with chronic disease or in need pain relief. Through our scientific and technology capabilities, the team continuously develops new and innovative methods to improve our products and services.
As an integral member of the Quality team, enable the delivery a safe quality aseptic manufacturing service to meet cGMP requirements and the needs of the business. The role holder will be expected to provide advice on all aspects of quality control to support the quality, efficacy and safety of all products manufactured at Bath ASU.
To manage the daily operation and development of the quality control department contributing to the Quality oversight of all operations at Bath ASU and the effectiveness and efficiency of the Quality Team.
Primary duties & responsibilities
- Management of the QC team to ensure all their tasks and responsibilities are achieved in a timely manner and to an appropriate standard.
- To hold regular meetings with the QC team to discuss actions for the week.
- To work in the Quality Control Laboratory in a safe and effective manner and in accordance with the recommendations of the Guide to Good Laboratory Practice, local procedures and all relevant safety regulations including Control of Substances Hazardous to Health (COSHH) and report risks and poor practices.
- Schedule and assist with routine 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, root cause investigation and preventative measures.
- Complete a variety of tests on microorganisms to confirm their identity.
- Manage the requalification, calibration and validation schedule in relation to QC tasks to ensure that relevant equipment at Bath ASU is maintained in a validated state in accordance with required frequencies.
- To ensure QC attend daily compliance meeting and give feedback on issues from the previous day.
- Liaise with Production Management to schedule monitoring of Production areas.
- Ensure stocks of materials and consumables are maintained at stated levels. Generate orders, receive and check off deliveries.
- Ensure that all QC facilities and equipment are kept clean and tidy. Recognise and report potential problems.
- Adhering to procedures and reporting deviations and changes.
- Maintain and approve the training records for all QC team members and ensure they are complete and kept up to date.
- Perform appraisals, assessing performance, objective setting, and developing action plans for the QC team
- To oversee and deliver training to the QC team to ensure they possess the required skills and knowledge to perform their roles.
- Review of QC team leave requests and maintenance of staff rotas to ensure adequate resource is always available.
- Produce trend and analysis reports as required by the QA Manager to support the oversight of QC related data
- Escalation of issues to the Head of Quality / QA Manager.
- Assist with periodic Regulatory GMP/ GDP Inspections and site preparation
- Lead QC investigations to determine root cause and identify effective CAPA
- Participate in the out of hours rota system for monitoring the environmental status of the building and its equipment.
Secondary duties & responsibilities
- Undertake routine analysis on a range of products including raw materials, containers/packaging, and finished products according to the appropriate Standard Operating Procedure.
- Assist with operator validations.
- Assist with quality improvement activities and on-going projects as required within the Quality Management System.
- To ensure QC procedures are accurate and update procedures when required.
- Perform validation of equipment and be involved in the generation of validation documentation and ensure PPM schedule is adhered to.
- Maintenance of filing of all relevant records, reports and other documentation associated with QC, record any anomalies and report appropriately.
- To support the training and development of Production and QA staff.
- To communicate with external agencies where appropriate, including QC laboratories, Manufacturers and Consumers (i.e. obtaining Certificates of Analysis/Documentation)
- To participate in a personal development programme to ensure skills and knowledge are maintained and advanced in accordance with the needs of the post-holder and the service requirements.
- Commitment to participate in any extended hours or Bank Holiday rotas, when required to meet needs of service.
In return we offer rewards and benefits including:
- Competitive salary
- 29 days holiday inclusive of bank holiday (increasing with service)
- Generous Pension scheme
- Life Assurance
- Quarterly Company bonus scheme
- Additional non-contractual benefits including free breakfast and outdoor gym