QA Microbiology Jobs at Pelltech Healthcare – Apply Online On Biotecnika
QA Microbiology
Company – Pelltech Healthcare
Budget – Up to 5 LPA
Interview – Virtual mode
Location – Maharashtra
Requirements – Micro reviewer + QMS knowledge
Experience – 3-5 years
To ensure microbiological quality assurance and compliance of pharmaceutical products by overseeing and validating microbiology lab activities, documentation, and adherence to cGMP, regulatory guidelines, and company SOPs.
Key Responsibilities:
1. Microbiological Testing & Daily Lab Operations
Sampling and testing of:
□ Raw materials (API & excipients)
□ In-process materials
□ Finished products
□ Stability samples
□ Routine testing:
□ Total microbial count (bacteria/fungi)
□ Pathogen detection (E. coli, Salmonella, P. aeruginosa, S. aureus)
□ Water testing: Purified Water (PW), Water for Injection (WFI), and Potable Water
□ Swab testing for equipment and personnel hygiene
□ Environmental monitoring of manufacturing areas:
□ Air sampling (viable and non-viable particles)
□ Settle plate analysis
□ Contact plate and swab testing on surfaces
□ Compressed air and gas monitoring
2. Documentation & Compliance (Lab-QA Functions)
Preparation and review of:
□ Standard Operating Procedures (SOPs)
□ Specifications and test methods
□ Analytical and microbiological reports
□ Ensuring GDP (Good Documentation Practice) and ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate + Complete, Consistent, Enduring, Available)
□ Routine checks and approval of logbooks, analytical data, and lab records
□ Involvement in data integrity audits and ensuring lab systems are 21 CFR Part 11 compliant (if applicable)
3. Instrument Handling, Calibration & Qualification
Operation, maintenance, and calibration of instruments like:
□ Incubators, BOD incubators
□ Laminar air flow units (LAF)
□ Particle counters (non-viable monitoring)
□ Autoclaves and hot air ovens
□ pH meters, conductivity meters
□ Ensuring timely calibration and preventive maintenance as per schedule
□ Preparation of equipment qualification protocols and reports (IQ/OQ/PQ)
4. Validations & Support to Production
Participation in:
□ Cleanroom validation (viable & non-viable monitoring)
□ Disinfectant efficacy studies
□ Media fill validation for process simulation (if sterile environment is involved)
□ HVAC validation support
□ Support in vendor qualification for microbiological consumables (media, reagents, disinfectants)
5. Deviation, OOS, OOT & CAPA Handling
□ Root cause analysis for any deviations, out-of-specification (OOS), or out-of-trend (OOT) microbiological results
□ Initiation and follow-up of corrective and preventive actions (CAPA)
□ Support in market complaint investigation related to microbiological quality
6. Audits, Regulatory Compliance & Training
□ Prepare for:
□ Internal GMP audits
□ External regulatory inspections (USFDA, MHRA, ANVISA, WHO, etc.)
□ Customer audits
□ Documentation support for Site Master File (SMF), Validation Master Plan (VMP), and Product Dossiers
Experience: 3-5 years of experience as a QA microbiologist or related
Educational Qualification:
· B.Sc. in Microbiology / Biotechnology
· M.Sc. in Microbiology / Biotechnology
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