Experience: 5+ years in pharmaceutical microbiology preferred
Qualification: M.Sc. Microbiology or a relevant postgraduate qualification
Role overview
We are seeking a Microbiologist to help establish and operate the microbiology laboratory and monitoring programmed for a non-sterile pharmaceutical facility.
Key responsibilities
- Prepare microbiology SOPs, specifications, test methods, sampling plans, worksheets and records.
- Perform microbial enumeration, tests for specified microorganisms and method suitability work, as applicable to raw materials, water and finished products.
- Plan and perform purified-water sampling and microbiological testing; maintain point-wise records and review trends.
- Establish environmental monitoring procedures, sampling locations, frequencies, alert/action limits and trend reports in coordination with QA.
- Manage media preparation, sterilization, growth-promotion testing, media inventories and related records.
- Maintain reference cultures,
culture handling records, equipment logbooks and calibration or qualification schedules.
- Support qualification of microbiology equipment and areas, and document the associated studies.
- Review raw data, identify atypical results and investigate excursions or OOS findings with QC and QA.
- Train laboratory staff in microbiology methods, aseptic technique, contamination control and documentation.
- Present microbiology systems and records during inspections and customer audits.
Candidate profile Applicants should have practical experience in non-sterile pharmaceutical microbiology, including water testing and environmental monitoring. Strong documentation, investigation and data-review skills are essential. Experience setting up a current microbiology laboratory is an advantage.