Officer -QC Microbiology (Male Only) For Pharma Formulation plant Pune

Roles and Responsibility:

1.Sampling Activities

• Carry out sampling of Raw Water, Potable Water, and Purified Water as per approved SOPs and schedules.
• Perform sampling of Active and Inactive Raw Materials while ensuring contamination-free handling and proper labeling.
• Collect samples of Finished Products and Stability Study samples for microbiological and analytical testing.

2. Microbiological Testing

• Perform Microbial Limit Tests (MLT) for:
• Raw materials
• Finished products
• Stability samples
• Conduct Environmental Monitoring (EM) of classified production areas including:
• External and Oral Preparation areas
• Microbiology laboratory
• Warehouse sampling and dispensing areas
• Laminar Air Flow (LAF) and Reverse Laminar Air Flow (RLAF) units
• Execute Personal Monitoring of personnel from Production, Warehouse, and Microbiology departments to ensure hygiene compliance.

3. Media & Culture Management

• Prepare, utilize, and maintain records for culture media as per approved procedures.
• Perform Growth Promotion Test (GPT) and Growth Inhibition Test (GIT) for media qualification.
• Conduct media and microbial culture deactivation following biosafety and waste disposal guidelines.
• Carry out sub-culturing, inoculum preparation, and purity & identification testing of microbial cultures.
• Maintain proper documentation for media preparation, consumption, and disposal.

4. Environmental & Facility Monitoring

• Monitor and record temperature and humidity on a daily basis.
• Monitor and maintain differential pressure and UV burning records for controlled areas.
• Perform fogging operations as per schedule and maintain related records.

5. Instrument & Equipment Handling

• Conduct daily calibration of pH meters and verification of analytical balances, maintaining accurate records.
• Perform monthly calibration of analytical balances.
• Carry out calibration of:
• Antibiotic Zone Reader
• Colony Counter
• Autoclave
• Micropipettes
• Ensure cleaning of instruments and equipment as per defined frequency.
• Maintain instrument and equipment usage logbooks.

6. Sterilization & Disinfection

• Sterilize media, glassware, and garments using validated methods and maintain sterilization records.
• Prepare disinfectants as per defined frequency for:
• Area cleaning
• Hand sanitization
• Maintain preparation and usage records for disinfectants.

7. Analytical & Assay Activities

• Perform Antibiotic and Vitamin Assays for:
• Raw materials
• In-process samples
• Finished products
• Prepare Analytical Method Validation (AMV) protocols and reports.
• Prepare and qualify Working Standards and maintain complete documentation.

8. Documentation & Compliance

• Strictly follow Good Laboratory Practices (GLP) in daily activities.
• Maintain all records in compliance with Good Documentation Practices (GDP).
• Ensure data integrity, traceability, and audit readiness of all laboratory records.

9. General Responsibilities

• Support seniors and management during emergency or urgent situations as assigned.
• Comply with company SOPs, safety policies, and regulatory guidelines.
• Assist during internal audits, external audits, and regulatory inspections when required.
• Handling of microbiological culture & maintain related records incuclum preparation of microbial culture.

Skills & Competencies

• Strong knowledge of GMP, GLP, GDP
• Hands-on experience in microbiological and analytical testing
• Good understanding of environmental monitoring and aseptic practices
• Proficient in laboratory documentation and compliance
• Ability to work independently and as part of a team