Skills And Tools:
The Microbiology section head's main objective is: -Providing leadership and direction to microbiology staff members through planning and designing work instruction and schedules for performance of all jobs pertaining to the scope of microbiological control assessment and raw materials, finished products, utilities and manufacturing sites environment.
- 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 performed 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.
- Train, coaches and assists staff in developing performance standards.
- Meets regularly with staff to discuss and resolve workload and technical issues.
- BSc. Of pharmacy or Science preferably in Microbiology.
- Minimum of 7 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
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