11 Oct
|
BioMatrix Healthcare
|
Ahmedabad
11 Oct
BioMatrix Healthcare
Ahmedabad
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 Valuable Documentation Practices (GDP).
- Capable of coordinating routine microbiological testing, investigations, documentation, compliance activities, and laboratory quality-system requirements.
- Interested Candidate can contact - (phone hidden)
📌 QC - Microbiology (Ahmedabad)
🏢 BioMatrix Healthcare
📍 Ahmedabad