Microbiology jobs

Preferred:

Recognition is given to Prior Learning and practical experience.

• At least 1- 3 years’ experience in vaccine / pharmaceutical / biotech manufacturing industry with QC Laboratory,

• Demonstrated competency in laboratory skills, including documentation,

• Experience in quality and regulatory compliance within a cGMP facility.

Preferred:

• Working knowledge of Pharmaceutical related legislation

• Previous participation in quality audits

• Experience in aseptic (sterile) manufacturing

• Working knowledge of testing techniques in instruments in Microbiology

• Ensure Microbiology Laboratory activities are planned and executed to meet quality, schedule and safety requirements

• Performing routine Microbiology testing (including utilities testing, media testing, raw material, in process and final product testing, e.g., TVC, Sterility testing, growth promotion testing, microbial identification testing, disinfectant and preservative efficacy testing, biological indicator population testing, etc.),

• Management of environmental monitoring samples, including timeous incubation, transfers, reading and interpretation of results

• Performing non-routine Microbiology testing (e.g., investigational tests, tests from Validation department, stability testing)

• Accountable for ensuring competency in multiple Microbiology test benches by actively driving and completing training on the various Microbiology test benches,

• Reviewing of Microbiology testing raw data, results, reports and logbooks related to Microbiology testing,

• Compiling laboratory reports related to Microbiology testing,

• Sampling of clean utilities (WFI, compressed air, nitrogen, pure steam) and provide back-up support for Environmental Monitoring,

• Ensuring cleanroom gowning competency required for utilities and EM sampling and other investigative purposes,

• Contribute to effective continuity cover and good employee relations in line with labour legislation and company policies,

• Ensuring competency on Biovac’s environmental monitoring management system (i.e., Sherpa)

Technology Transfer and Projects Support:

• Participating in technology transfers from other vaccine manufacturers and other project activities from a Microbiology perspective,

• Compiling Protocols, reports and test methods for Microbiology analytical development, analytical verification, and analytical validation activities,

• Performing Microbiology testing for analytical development, analytical verification, and analytical validation activities.

Good Laboratory Practices:

• Responsible for planning and coordination of daily and project activities in line with the QC Supervisor,

• Maintain work areas in a neat, clean, orderly, and inspection-ready state in accordance with 5S principles, ensuring clearly designated and appropriately managed storage of consumables, components, and equipment.

• Executing laboratory operations at cGMP standards to ensure quality, safety, and regulatory compliance,

• Controlling and managing stock related to Microbiology testing (routine, validation and other non-routine) and EM,

• Monitoring Microbiology equipment for maintenance, calibration and qualification statuses with escalations to the QC Equipment Lead and supervisor,

• Drafting, updating, proof reading and editing of procedures and test methods related to Microbiology testing

Quality & Compliance:

• Actively involved with OOS and/or OOT investigation related to Microbiology testing and EM (including MDDs) and ensuring that these are completed on time, and to the correct standard,

• Participate in quality events (deviations and incidents), change controls and CAPAs related to Microbiology testing and EM, maintaining a state of control of the quality management within the department.

• Ensure audit readiness at all times, participate in cGMP audits and implement corrective actions where relevant.

• Committed to adhering to company Quality and Compliance standards

• Committed to adhering to company Data Integrity policies

• Participate in building a sustainable quality culture on site

• Ensure timely and effective communication by escalating quality issues to the appropriate levels of management.

Sterile Support

• Completing trend analysis from EM and other test results,

• Providing support in investigations related to Sterility Support in the production facilities and the laboratory

• Assisting with implementation of the Contamination Control Strategy (CCS) for the site

• Implementing new tests and new technologies and participation in the qualification of related equipment related to Microbiology testing.