Microbiology Section Head

Job Responsibilities:

• 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.

Job Requirements

• 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