Website:
mmjconsulting.in
Job details:
Job Summary
We are seeking a detail-oriented and quality-driven Microbiologist Lab Technician to join our pharmaceutical manufacturing team. The successful candidate will be responsible for performing microbiological testing, environmental monitoring, quality control analyses, and laboratory documentation to ensure compliance with GMP, GLP, WHO, and applicable regulatory standards. The role is critical in maintaining product quality, safety, and microbiological integrity throughout the capsule manufacturing process.
Key Roles & Responsibilities
- Perform routine microbiological analysis of raw materials, finished products, purified water, and in-process samples.
- Conduct microbial limit tests, total viable count (TVC), pathogen testing, and sterility-related examinations as per approved SOPs.
- Carry out environmental monitoring of manufacturing areas, clean rooms, air, surfaces, personnel, and equipment.
- Prepare, sterilize, and maintain microbiological culture media, reagents, and laboratory solutions.
- Operate, calibrate, clean, and maintain laboratory equipment, including autoclaves, incubators, laminar airflow cabinets, colony counters, pH meters, and analytical instruments.
- Perform microbial identification and record analytical observations accurately.
- Ensure laboratory activities comply with Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), Standard Operating Procedures (SOPs), and quality management systems.
- Maintain accurate laboratory records, logbooks, batch documentation, test reports, and electronic data with complete traceability.
- Participate in Out of Specification (OOS), Out of Trend (OOT), deviation investigations, CAPA implementation, and root cause analysis.
- Support validation and qualification activities, including cleaning validation, media fill support, and microbiological method verification where applicable.
- Monitor laboratory inventory, culture media stock, chemicals, microbiological consumables, and testing materials.
- Ensure proper handling, segregation, and disposal of microbiological waste according to safety and environmental guidelines.
- Coordinate with the Quality Assurance (QA), Quality Control (QC), Production, and Engineering departments to resolve microbiological concerns.
- Participate in internal audits, external audits, regulatory inspections, and customer quality assessments.
- Identify opportunities for continuous improvement in laboratory operations, testing efficiency, and compliance.
- Maintain laboratory hygiene, biosafety standards, and contamination control practices at all times.
- Perform any additional laboratory or quality-related duties assigned by management.
Required Technical Skills
- Microbiological Testing
- Environmental Monitoring
- Sterility Testing
- Microbial Limit Testing
- Culture Media Preparation
- Aseptic Technique
- Laboratory Documentation
- Quality Control (QC)
- Good Manufacturing Practices (GMP)
- Good Laboratory Practices (GLP)
- SOP Compliance
- Root Cause Analysis
- CAPA
- OOS & OOT Investigation
- Data Integrity
- Laboratory Instrument Calibration
- Clean Room Monitoring
- Pharmaceutical Manufacturing
- Capsule Manufacturing
- Nutraceutical Manufacturing
- Regulatory Compliance
- Documentation Management
Preferred Qualifications
- Bachelor's Degree or Diploma in Microbiology, Biotechnology, Life Sciences, or a related discipline.
- Experience in a pharmaceutical, nutraceutical, capsule manufacturing, food manufacturing, or healthcare laboratory environment is preferred.
- Knowledge of GMP, GLP, WHO, ISO standards, and microbiological quality control procedures.
- Strong analytical, documentation, communication, and problem-solving skills.
- Ability to work independently as well as collaboratively in a fast-paced manufacturing environment.
Microbiologist • Microbiology Lab Technician • Pharmaceutical Manufacturing • Capsule Manufacturing • Quality Control • Quality Assurance • Environmental Monitoring • Sterility Testing • GMP • GLP • SOP • Laboratory Testing • Microbial Analysis • Pharmaceutical Quality • Nutraceutical Manufacturing • Microbial Limit Test • Regulatory Compliance • Clean Room • Validation • CAPA • OOS Investigation • Root Cause Analysis • Laboratory Operations • Kolkata Jobs • West Bengal • Pharma Jobs • QC Microbiology • Production Support
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