The role of the Microbiology Supervisor is to coordinate and ensure that team objectives are achieved, and operational decisions made and executed in a timely manner
To effectively manage the specified team providing direction and co-ordination of all activities to ensure compliance with regulatory requirements and company SOPs. To ensure that all scheduling requirements are met, in conjunction with other departments where required.
To provide technical leadership and to co-ordinate the activities of work allocated to the team of analysts; specifically, the testing of Quality Control samples and to support validation studies.
To support and manage organizational change and process improvements through development and coaching of a team. Maintain a presence within the laboratory area to monitor laboratory activities.Responsibilities
To manage a small team of 6-7 direct reports performing sickness absence, performance reviews and support of direct reports development opportunities.
To ensure appropriate standards of cGMP, housekeeping, Health, Safety and Environment are applied in the team, in accordance with current regulations and procedures guaranteeing that the area is permanently inspection ready.
- To schedule the activities of the team in accordance with the Lean Lab solution, monitoring and approving holidays, sickness absence and training/competence position of all associates. The monitoring of associated KPIs being used to adapt plans accordingly.
- To review and approve data generated from testing and to bring to the attention of the Team Manager and other site personnel, test results and any trends, out of specification results. In addition, where appropriate perform the required transactions to release materials.
- To ensure that the maintenance and qualification of the specified laboratory and equipment within is up to date and at the required GMP standards. To ensure the use only of approved and validated test processes.
- To co-ordinate department cGMP systems, such as deviation management, closure of corrective and preventative actions, change controls and SOPs.
- To participate in improvement project teams where required driving quality decisions and provide advice and technical support where required. Coordinate completion of any resulting activities.
- To lead troubleshoot in the resolution of testing problems involving your team and relevant customers/suppliers. Demonstrate creative problem solving within cGMP constraints and align with best practice.
- To track the team ensuring that mandatory training is in place. To encourage optimal performance of staff through training, feedback every two months and development planning in conjunction with the Team Manager
Graduate level in relevant discipline or suitable alternative or equivalent experience within industry.
cGMP background in the Pharmaceutical industry
Experience of Quality Control testing techniques and industry practices.
Authors protocols and reports for suitability studies and investigations to support testing and compliance issues
Ensures laboratory instruments are qualified, calibrated and properly maintained and documentation complies with cGMP standards
Assists in development of new methods and procedures and maintains standard operating procedures (SOPs)
Documents quality issues and performance measures for management review
Minimum 3 years working within a QC Laboratory with laboratory scheduling/people management experience preferable.
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