QC Microbiologist (Pharmacetutical)

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Below is a Job Description (JD) for a QC Microbiologist in a pharmaceutical manufacturing unit. You can copy, edit, or ask me to tailor it to your company, experience level, regulatory region (US FDA, EU GMP, WHO, MHRA), or dosage forms.

Job Description – QC Microbiologist (Pharmaceutical Manufacturing Unit)Position Title: QC MicrobiologistDepartment: Quality Control – MicrobiologyReports to: QC Microbiology Manager / QC HeadLocation: Pharmaceutical Manufacturing Facility1. Job Purpose

To conduct microbiological testing of raw materials, water, in-process samples, finished products, and environmental samples to ensure compliance with regulatory guidelines and maintain product quality and safety.

2. Key ResponsibilitiesA. Microbiological Testing

• Perform Sterility Testing, Bacterial Endotoxin Testing (BET/LAL), Microbial Limit Tests (MLT), Bioburden analysis, and Microbial identification.
• Execute Growth Promotion Tests (GPT) for media.
• Conduct Environmental Monitoring (EM) of production areas:
• Settle plates
• Active air sampling
• Surface and personnel monitoring
• Compressed air/gas testing
• Perform Water testing (PW, WFI, utility water):
• TVC
• Endotoxin
• Conductivity
• TOC (if required)

B. Documentation & Compliance

• Prepare and maintain SOPs, STPs, GTPs, and logbooks.
• Ensure all activities comply with cGMP, GLP, GDP, and regulatory guidelines.
• Record data in Good Documentation Practice format (ALCOA+ principles).
• Participate in investigations, including OOS, OOT, deviations, and CAPA implementation.

C. Instrument Operation & Maintenance

• Operate and calibrate instruments such as:
• Laminar Air Flow (LAF)
• Incubators
• Autoclaves
• Biological safety cabinets
• pH meter
• Colony counter
• Microscopes
• Endotoxin testing systems (e.g., Kinetic LAL reader)
• Ensure proper qualification: IQ, OQ, PQ compliance.

D. Validation Activities

• Participate in:
• Method validation
• Disinfectant efficacy studies
• Media fill (aseptic process simulation)
• Water system validation/monitoring
• Cleaning validation (micro level)

E. Training & Continuous Improvement

• Follow and execute training on microbiological techniques.
• Suggest process improvements to enhance laboratory efficiency and compliance.
• Support regulatory inspections (FDA, WHO, MHRA, PIC/S, etc.).

3. Qualifications

• B.Sc / M.Sc in Microbiology / Biotechnology (or related discipline).
• 0–5+ years of QC microbiology experience in a pharmaceutical manufacturing environment (Tablets, OSD.).

Job Types: Full-time, Part-time

Pay: ₹20,000.00 - ₹30,000.00 per month

Work Location: In person