To support the Manufacturing and Quality Control functions by developing, reviewing, scheduling, organizing, and performing tests on raw materials, packaging, intermediates, finished products, stability study sample and environmental monitoring.
Duties and Responsibilities:
- To plan and ensure microbiological test on raw materials, work in progress, stability study samples and finished products are analyzed correctly and in timely manner and results are delivered within the agreed time frames.
- To review microbiological test results and reports prepared by laboratory analyst / technician.
- To schedule and ensure production blocks environmental monitoring are carried out as per planned.
- To review environment monitoring results and reports for Production Block and Microbiology Laboratory.
- To review testing on microbial assay.
- To provide support in microbial sampling, identification, bio-burden testing in manufacturing facilities and critical system.
- To develop and coordinate test method validation to assure methods comply with current pharmacopeia requirement.
- To review Standard Operating Procedure and Work Instruction to assure procedures comply with current pharmacopeia/cGMP/regulatory requirement.
- To ensure equipment in Microbiology Laboratory is maintained in good working condition and scheduled performance check and calibration are done.
- To identify the training needs for each microbiology laboratory members and develop training plan.
- To ensure only qualified microbiologist / laboratory analyst /technician performs testing.
- Ensure availability of training materials for Sterile Manufacturing Staff as per current regulatory requirement.
- To train and qualify Sterile Manufacturing Staff on environmental monitoring sampling procedure.
- To review the gowning qualification report of the staff entering to Sterile Manufacturing Area.
- To ensure consistent supplies of consumables used in the laboratory, including sourcing, quotation request, raising Purchase Requisition and follow up on the delivery.
- To review microbiological environmental monitoring data on periodic basis and provide trending for analysis and approval.
- To prepare protocol, execution and report write up for Media Fill and Steam Sterilization mapping.
- To follow documented procedures and comply with ISO/IEC 17025 requirements.
- To perform any other duties as assigned by superior via special or ad hoc requests.
- To escalate to the QC Manager and QA Manager in the event of root cause analysis for Out-of-Specification and Out-of-Trend, and participate in the investigations activities and reporting.
- To ensure implementation of Continual Improvement Program.
- A Bachelor’s Degree in science and at least 5 years of relevant experience as a Microbiologist.