QC - Microbiology

BioMatrix Healthcare Pvt Ltd.; Ahmedabad District; On-site; INR 600,000 - 900,000; Full time

Benefits offered by this job

Onsite role

Job summary

BioMatrix Healthcare Pvt Ltd. Ahmedabad is seeking professionals with extensive microbiology testing expertise to perform MLT, sterility, BET, PET, and related assays in a GMP environment.

The role covers media prep, culture handling, environmental monitoring, and water analysis, with emphasis on data integrity and regulatory readiness. The candidate will contribute to validation activities, instrument calibration, and audit support, ensuring compliance with USFDA, WHO-GMP, NABL, and EU-GMP

Qualifications

• Experience in microbial testing and GMP-compliant laboratory practices.
• Strong knowledge of MLT, Sterility Testing, BET, PET.
• Experience with environmental monitoring and water analysis.

Responsibilities

• Experienced in performing Microbial Limit Tests (MLT), Sterility Testing, Bacterial Endotoxin Test (BET), and Preservative Efficacy Test (PET) in accordance with approved procedures and GMP requirements.
• Hands-on experience in media preparation, sterilization, growth promotion testing, media hold-time studies, and culture handling.
• Environmental monitoring of pharmaceutical microbiology areas, including sampling, testing, result evaluation, and trend analysis.
• Water analysis, including microbiological examination of pharmaceutical water systems and interpretation of results against approved specifications.
• Bioassay testing and microbiological testing activities as per approved methods and protocols.
• Disinfectant efficacy studies and evaluation of disinfectant effectiveness against specified microorganisms.
• Autoclave validation, routine monitoring, and validation-related microbiological activities.
• Instrument calibration, qualification support, and maintaining laboratory equipment records in compliance with GMP requirements.
• Method validation/verification and preparation of validation protocols, reports, and supporting documentation.
• Audit management and regulatory inspection support including USFDA, WHO-GMP, NABL, and EU-GMP audits/inspections.
• Adherence to approved SOPs, specifications, test methods, safety requirements, data integrity principles, and GDP.
• Coordinate routine microbiological testing, investigations, documentation, compliance activities, and laboratory quality-system requirements.
• Interested Candidate can contact - 9227725188

Skills

GMP compliance

Microbiology testing

Environmental monitoring

Disinfectant efficacy studies

Tools

Media preparation

Autoclave validation

Instrument calibration

Job description

2519Role & responsibilities

• Experienced in performing Microbial Limit Tests (MLT), Sterility Testing, Bacterial Endotoxin Test (BET), and Preservative Efficacy Test (PET) in accordance with approved procedures and GMP requirements.
• Hands-on experience in media preparation, sterilization, growth promotion testing, media hold-time studies, and culture handling, including culture dilution, maintenance, and preservation.
• Experienced in environmental monitoring of pharmaceutical microbiology areas, including sampling, testing, result evaluation, and trend analysis.
• Proficient in water analysis, including microbiological examination of pharmaceutical water systems and interpretation of results against approved specifications.
• Experienced in bioassay testing and microbiological testing activities as per approved methods and protocols.
• Hands-on experience in disinfectant efficacy studies and evaluation of disinfectant effectiveness against specified microorganisms.
• Experience in autoclave validation, routine monitoring, and validation-related microbiological activities.
• Responsible for instrument calibration, qualification support, and maintaining laboratory equipment records in compliance with GMP requirements.
• Experience in method validation/verification and preparation of validation protocols, reports, and supporting documentation.
• Experienced in audit management and regulatory inspection support, including USFDA, WHO-GMP, NABL, and EU-GMP audits/inspections.
• Ensure adherence to approved SOPs, specifications, test methods, safety requirements, data integrity principles, and Good Documentation Practices (GDP).
• Capable of coordinating routine microbiological testing, investigations, documentation, compliance activities, and laboratory quality-system requirements.
• Interested Candidate can contact - 9227725188