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. Robust documentation, investigation and data-review skills are essential. Experience setting up a current microbiology laboratory is an advantage.