Executive QC Microbiology For Pharma Formulation plant Pune.
- Veko Care
- 3 - 6 years
- Pune
- 16 days ago
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Job Description
Roles and Responsibilities:
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
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Quality AssuranceRole Category: Quality Assurance - OtherRole: Quality Assurance - OtherEmployement Type: Full timeContact Details:
Company: Veko CareLocation(s): Pune
Keyskills: Microbiolgical testing Raw Material Media & culture management Compliance Environment & Facility Management Documentation Sample activities Sterlization and disinfection Analytical & Assay Activities Instrument Handling General Responsibilities
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