QC Microbiology Manager - GMP - £60k- £70k + Bonus
QC Microbiology Manager - GMP - £60k- £70k + Bonus - Pharmaceuticals - Medical Device - ISO 13458 - ISO 9001 - Steriles
A leading international healthcare company require a QC Microbiology Manager to join its team in Surrey. You will have overall responsibility for the management of the day to day laboratory testing activities associated with the Microbiology and Chemistry QC departments. You must be an experienced manager with significant experience within pharmaceutical microbiology.
You will develop and implement strategies to ensure that the Quality Control work in the laboratories complies with the appropriate Regulatory and Safety standards specifically those relating to cGMP, while driving quality improvements of products and processes through active participation in inter-departmental areas.
*Lead and manage a laboratory operation, which includes the QC testing of raw materials, excipients, components, in process intermediates and finished products such that results are generated in a timely manner according to established written procedures and GMP.
*Manage the company's environmental monitoring, and critical utilities monitoring program (purified, pure steam and WFI water systems) in all GMP aspects. Responsible for the evaluation of manufacturing environment against international standards of operation.
*Ensure the laboratory provides an effective and efficient service to production, planning, warehousing and shipping departments, therefore enabling customer requirements to be met. Accountable for inventory, cost, cycle-time, and customer service targets, and is responsible for managing events that impact upon these targets.
*Manage the team of Senior QC Scientists, QC Scientists and Associate QC Scientists and Microbiologists
*Evaluation of test methods against current EP, USP and industry regulatory standards.
*Review and approve reports, investigations, validations required by company.
*Responsibility for setting budgets for the laboratory function and maintaining control of expenditure. Responsible for setting and prioritising CAPEX expenditure on laboratory equipment.
*Provides input to the QA Manager/OP and Wider Leadership Team to resolve issues identified on a daily, weekly and monthly basis.
*Participates in all daily walk through and communicates the status of laboratory activities. Relay the Quality Control perspective and recognize & understand the wider business perspective.
Through the use of performance metrics monitor laboratory efficiency and ensure that systems remain effective. Ensure that systems are adapted and improved in order to maintain efficiencies and also refocus priorities in line with business needs.
*Participate in internal audits. Actively participate in regulatory and customer audits.
*Identifies, priorities, and champions continuous improvement projects in the Laboratory to deliver improvement targets through the use of appropriate Lean tools (such as VSM, 5S, Lean, Enabling Projects implementation and control etc), including the implementation of improvement projects to reduce process variability and eliminate waste.
*Support and participate in Company Projects, quality initiatives and continuous improvement programs within Quality Assurance and the Farnham Site.
*Maintain knowledge of current technology, regulatory changes, CGMP/GLP and future/proposed changes, consider any impact of changes and advise personnel accordingly. Implement changes to working practices in accordance with CGMP/GLP and other changes.
*Manage laboratory validation activity and status to ensure that regulatory standards are maintained.
*Provide technical expertise and leadership in the area of laboratory activities. Manage the investigation and documentation of OOS/OOT/MLE results and incidents I deviations generated within the QC department. Liaise with other department managers to ensure thorough fact and scientific based reports are provided to enable correct quality and batch disposition decisions to be made.
*Develop structures and practices to effectively meet all laboratory deliverables. Develop structures to allow all personnel to work together in a productive and challenging environment. Mentor laboratory personnel and provide input and coaching on professional development and career paths. Provide timely feedback; and evaluates performance of direct reports after obtaining the relevant functional input and evaluation.
*Approve and monitor the contract test facilities to ensure the best level of service is provided to the Client.
*Highlight Training requirements and ensure they are met. Initiate personnel development programs for staff and assist with training around site.
*Ensuring that all interactions and engagements are carried out with the highest ethical and professional standards and that all work is accomplished with quality and in accordance with the Client's values.
*Carry out other reasonable tasks as required by the Line Manager.
Education and Experience
*Degree or equivalent preferably in a scientific or business-related discipline. An advanced Management degree (MBA) or equivalent is desirable.
*Significant microbiology experience
*Chemistry QC knowledge is desirable
*Extensive experience working in the Pharmaceutical, Devices or related industry with a working knowledge of the requirements of the MHRA and FDA essential, along with understanding of ISO requirements and experience of sterile products.
*Excellent understanding and hands-on working knowledge of cGMP, quality and regulatory environment and inspection process for clinical and commercial material