Reporting to: Quality Manager
EXPERIENCE / QUALIFICATIONS
- Must have a minimum of Three years industrial experience in a GMP regulated QC chemistry laboratory.
- A degree in Analytical Chemistry, Pharmaceutical Chemistry or other related qualification is required.
DUTIES & RESPONSIBILITIES
- Ensuring that all operations within the chemistry laboratory are performed in accordance with applicable regulations, standards and guidelines.
- Selection, installation, qualification and ongoing maintenance of laboratory equipment in accordance with the CLS laboratory quality system and GMP.
- Generation of documentation to support test method transfers from clients.
- Execution of testing as per approved protocols and test method etc.
- Write up of all test results as per GMP and in accordance with the Quality System including Out of Specification results and Laboratory Deviations.
- Review and approval of Laboratory quality records as per GMP and in accordance with the Quality System e.g. Out of specification results, laboratory deviations etc.
- Training of junior staff.
- Participation in self inspections audits.
- Communicate with customers in relation to technical queries, forecasting etc.
- GMP review of Laboratory log books.
- Participate in Laboratory audits e.g. Regulatory Customer.
- Interpret analytical results and resolve technical and/or operational problems and provide technical advice and support to all technicians/analysts.
- Prepare, review and revise, as required, SOPs and specifications. Initiate and review out of specification and deviation reports, protocols and other appropriate documentation for proper functioning of the lab operation.
- Support and manage projects to be on time, within budget and to meet business requirements.
- Ensure the validation status for all test methods and laboratory equipment is compliant with regulatory requirements and internal procedures.
Please email your application letter and C.V. to Miriam Murphy: firstname.lastname@example.org