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Job Description
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Ensures the development, implementation, and maintenance of quality control microbiology systems and activities.
Designs work objectives to achieve microbiological control for raw materials and products. - Schedules, coordinates and monitors a wide variety of microbiological, biological tests which are preformed in accordance with approved protocol.
- Participates in validation protocols of manufacturing sites and equipment.
- Carries out microbial quality control tests and generates challenge test data.
- Provides guidance to the microbiology team on the application of the internal and external regulatory requirements.
- Conducts internal audits on department test methods and activities to confirm compliance and to identify improvement.
- Designs laboratory requirements with respect to facilities, equipment and instrumentation.
- Maintains laboratory equipment in line with preventative maintenance schedules.
- Develops and revises laboratory procedures in accordance with current testing guidelines and good manufacturing procedures.
- Review and approve of documentation including SOP, logbook, validation protocols, reports and associated deviations.
- Samples, inspects, analyses and records accurately raw materials, intermediates and final products.
- Implements standards, methods and procedures for inspecting, testing, and evaluating the quality attributes of products, including the collection and administration of environmental monitoring data, testing, utilities and microbial identification.
- Releases products from testing once all criteria are met, as specified in the procedures and testing specifications
- Implement, maintain and improve the management system.
- Identify the deviations from the management system or from the procedures for performing laboratory activities.
- Initiate actions to prevent or minimize deviations.
- Report to lab management on the performance of the management system and any need for improvement ensuring the effectiveness of lab activities.
Job Requirements
- B. Sc. Of pharmacy or Science preferably in Microbiology.
- Minimum of 8 years of experience in the pharmaceutical microbiological laboratory.
- Able to carry out laboratory work in accordance with laboratory procedures.
- Accurate generation, recording and presentation of test results.
- Must have the ability to accurately execute protocols and prepare draft reports with supervision.
- Ability to meet workloads and project deadlines.
- Excellent English, verbal / written communication
- Ability to work well through others
