Lead - Lab Microbiologist, ACG Capsules (Quality) ACG World

3.0 - 5.0 years

0 Lacs

Dahanu, Maharashtra,

On-site

Qualification Required And Experience Qualification - MSC (Microbiology & Biotechnology) Exp - 3 to 5 Years Primary Responsibilities P lan for sampling & testing of raw materials, finished products, in-process samples, swabs, air and water, stability samples as per the given QC plans and customer specifications for microbiological testing and monitoring Sampling and Environmental monitoring Analysis and reporting (including SAP entry and COA) Trending, Investigation and CAPA for microbiological failures Surveillance for microbiology compliance Calibration and validation (testing support, laboratory equipment qualification, method validation, disinfectant validation) GLP and documentation, laboratory facility maintenance Release of raw material (in absence of QC Head) Preparation of Microbial SOPs and STPs Participate in various quality improvement programs and organizational initiatives Isolation and identification of isolates and maintenance of standard culture Key Result Areas Perform complete Microbiological testing Lay down systems and practices for ensuring FTR, microbiological quality of products In order to ensure production and delivery of microbial compliant capsules Key Interfaces Timely completion and reporting of all Microbiological testing to enhance smooth production activity No external failures for microbiology No non-compliance in internal and external audits Improvement in microbiology trends Show more Show less

Posted 1 month ago

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Manager - QC Microbiologist Swiss Garnier Life Sciences

10.0 - 15.0 years

9 - 12 Lacs

sikkim

Work from Office

Roles and Responsibilities Conduct microbiological testing and analysis of raw materials, in-process samples, finished products, and environmental monitoring to ensure compliance with regulatory requirements. Develop, validate, and maintain microbiology protocols for water systems, disinfection processes, and media preparation. Collaborate with cross-functional teams to investigate out-of-specification (OOS) results and implement corrective actions. Ensure timely reporting of test results to relevant stakeholders and maintain accurate records according to cGMP guidelines. Participate in audits and inspections by providing documentation support. Desired Candidate Profile 10-15 years of experience in a pharmaceutical industry as a Microbiologist or equivalent role. Strong knowledge of MLT Method Validation, Water System Validation, Residual Efficacy Method Validation, Disinfectant Validation, Qualification of Biological Indicators, Media Self Life Validation, Autoclave Validation. Experience with microbial analysis techniques such as plate counting and identification methods.

Posted 2 months ago

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