QC Laboratory Manager - Wiltshire
Dept.: Analytical QC.
We are looking for a motivated individual to lead and manage a specialist GMP analytical chemistry/biochemistry laboratory to provide compliant testing of licensed pharmaceutical products; plus validation of analytical methods and expert support and advice to GMP product teams.
This position will lead approximately 19 staff consisting of Senior QC Analysts, QC Analysts and QC Technicians performing essential analysis on Biopharmaceutical products including release and stability testing.
The ideal candidate will have experienced of leading a team and extensive knowledge of analytical techniques. The successful candidate will be experienced in using quality management systems in the pharmaceutical industry and will be able to work to tight deadlines.
MAIN DUTIES AND RESPONSIBILITIES:
- To operate the QC Analytical Services Laboratory in compliance with safety policy and cGMP.
- To manage and lead the QC Analytical Services Laboratory and to meet manufacturing deadlines.
- Responsible for staff recruitment, appraisals and management to 'Policies and Procedures’ documents.
- Utilising technical skills to validate specialised chemical and biochemical tests procedures to internationally recognised regulatory guidelines.
- Train staff within the QC Analytical Services Department in laboratory techniques and Quality Management Systems to GMP requirements.
- Work with project teams and represent QC on these to contribute to the success of these business centres by delivering the required Analytical knowledge and services.
- Play a lead role with both internal and external customers.
- Maintain an up to date awareness of regulatory and scientific developments via approved training courses and meetings that will contribute to the efficiency and effectiveness of laboratory working practices and aid personal development.
- To ensure that clinical pharmaceutical products are tested from raw materials and in-process samples to finished products to demonstrate that they meet the specification prior to each batch release for administration to patients.
- Maintain a programme of constant improvement.
- Expenditure to financial limits.
- Sign off authority for Pharmaceutical batch release tests
- Review and approval of SOPs, Protocols and Risk Assessments.
Degree or equivalent in microbiology, chemistry or pharmacy
Significant relevant work experience in a GMP regulated environment.
Significant work experience and knowledge of pharmaceutical Quality Assurance, EU and US GMP.
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