- The Laboratory Analyst has responsibility for Raw Material, Intermediate and Drug Substance testing to meet compliance requirements and customer targets. The Analyst may also take a leadership role in change or improvement projects in ADC or at a site level.
- The Laboratory Analyst is responsible for ensuring all testing activities comply with cGMP. The Laboratory Analyst assures compliance with all safety and environmental requirements. Compliance with other regulated areas such as HR policies are also responsibilities of the role.
- To test Raw Materials, Intermediates,Drug Substance, Drug products in accordance with Quality Standard and/or other approved protocols.
- To comply with all GMP and analytical procedures relevant to area of work.
- To adhere and comply with department High Performance Analytical Behaviours
- To document all testing activities and to input results into computerised lab systems in accordance with department and MMD standards.
- To provide analytical support to product quality investigations and new product demonstrations under the supervision of the Laboratory Leader or designate.
- Complete the investigation of laboratory OOSs in line with site and divisional procedures.
- Complete documentation checks (e.g. PCR’s, ACRs, Deviations) as required for the Drug Substance/Drug Product test package prior to release.
- To complete testing as required on samples to support process changes.
- Accountable for own laboratory safety practices.
- To provide lead analytical support to product quality investigations and new product demonstrations using own initiative and with minimum supervision.
- Provide leadership in the laboratory aspects of OOS investigations.
- To identify and aid resolution of analytical issues within the IPT laboratory.
- To be a resource for analytical testing for the site as required.
- Execute specific assignments (e.g. stability programme, instrument management and other systems) in a comprehensive manner and under minimum supervision.
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