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Reporting to the QC Manager, the QC Team Leader will manage the day to day work of a team of analysts working in a pharmaceutical GMP QC laboratory. The role will include scheduling work, checking & reporting of results, release of products, qualification of equipment and/or methods, and any other customer requirements for the areas of responsibility assigned.
Key Responsibilities ·To supervise, train, and mentor QC team members and ensure that they work to cGMP at all times. ·Planning, prioritising, and managing the QC analysis for the areas of responsibility by co-ordinating with other QC Team Leaders, the QC Manager, and other departments (customers). ·Ensure that all analytical operations are performed in accordance with current cGMP regulations. ·Participate in the continuous trending, communication, and review of batch data. ·Leading and documenting laboratory OOS, OOE, and OOT investigations, identifying the root causes of problems and introducing effective corrective and preventative actions. ·Completion of deviation investigations, change controls, and any other QMS documents required. ·Creating and updating documents to a high standard and in accordance with cGMP and company procedures.
Essential Skills ·Educated to degree level in chemistry (or related science based subject) as a minimum. ·Training in, and experience of, leading a team in a pharmaceutical or other regulated laboratory. ·High level of knowledge and understanding of cGMP regulations. ·Knowledge and understanding of data integrity requirements. ·High level of knowledge and experience of QC analytical testing and the use, and troubleshooting of, analytical instrumentation. ·Knowledge of stability testing and associated guidelines. ·Experience of Pharmacopoeial testing and the use of Pharmacopoeias. ·Good communication, presentation, coaching/training, and team working skills. ·Computer literate. ·High level of numeracy. ·Excellent attention to detail and concern for quality'. ·Able to develop and maintain positive working relationships with others. ·Proactive and demonstrates a can do' approach.
Desirable: ·Experience in the qualification of laboratory instruments, validation of analytical methods, and computer systems validation in a cGMP environment. ·Experience of using the Empower CDS.