Job DescriptionWe are looking for an experianced QC microbiology manager with a good track record of managment in order to come on board and lead a large team movign forard through an exiting new phase of company development
JOB SUMMARY Accountable for leading a team to secure delivery of:
• The development of more public health interventions in shorter timescales.
• A reduction in regulatory hurdles in the development and release of existing and new products
• The targets and objectives agreed with line management.
• Specialist advice and represent the company during regulatory and customer audits. Accountable to the Head of Quality Operations for assisting in the delivery of autonomous and innovative leadership / management. To provide leadership and QC management of the microbiology department. To monitor performance of the QMS in place. To provide leadership, communication and expertise to continuously improve microbiology compliance across the comapny.
MAIN DUTIES AND RESPONSIBILITIES
• To work with other managers within the Quality team to ensure that manufacturing and quality activities are performed in compliance with all the regulations and other requirements including: The Rules & Guidance for Pharmaceutical Manufacturers' and Distributors, cGMP guidance, and other regulations governing comapny activities. • To lead projects and deliver required outcomes in own specialist area.
• To lead, motivate, coach, mentor and manage the performance and output of the Microbiology Team (including direct managerial reports) and ensure that all team objectives are met in agreed timescales.
• To maintain and develop the local standard operating procedures to secure effective working practices as well as compliance with relevant national, European and US legislation. • Monitor the performance of the systems under area of responsibility using KPIs and report to management. • Develop and implement an ongoing Quality Improvement Plan related to the systems under area of responsibility
• To lead the development and implementation of an ongoing Health & Safety Plan for the team to secure the right level of performance, highlight failures and make recommendations for solutions.
• In line with overall responsibilities, perform additional tasks assigned by the line manager.
- Trained microbiologist
- Significant experience of managing teams
- Experience of operating and managing quality systems for compliance to regulatory requirements (e.g. batch release, non-conformance, risk management) and a focus on continuous improvement.
- Experience of dealing with internal customers, negotiating and agreeing work programmes, reporting progress, dealing with issues to ensure delivery and customer satisfaction
- Substantial practical experience within a GMP environment, particularly in the context of biologics and steriles manufacture.
- Knowledge and experience of Aseptic Manufacture
- Must have operational knowledge of EU/US pharmaceutical regulatory requirements, particularly for biologics and sterile products.
Due to the nature of the work applicants must be able to provide proof of residance in the UK for 5 years inorder to provide a sufficant background check.