HiMedia Laboratories Private Limited is an Indian origin Bioscience company headquartered in Mumbai, Maharashtra, India. HiMedia is one of the most prominent biosciences companies in India. The company was established 48 years ago, by Dr. Gangadhar M. Warke, a soil Microbiologist, along with his wife, Mrs. Saroj G. Warke and his younger brother, Mr. Vishnu M. Warke. Today, HiMedia as an organization is engaged in developing, manufacturing, and selling of majority of bioscience-based products worldwide, and has expanded bases by establishing offices and warehouses in Europe and the USA.
Post : Assistant / Deputy, Manager Microbiologist QC / QA
Qualification : M.Sc, Microbiologist
Experience: 10-15 Years
Software Knowledge : MS Office, SAP( Preferred)
Location : Palkhed , Nasik.
Key Roles and Responsibilities
• Development and implementation of microbiology laboratory manual.
• Maintenance of inventory for Microbiology Laboratory.
• Willingness to keep up-to-date with current information as per guideline.
• Knowledge of water system & water testing as per regulatory guideline.
• Knowledge of QMS system like change control, deviation, Incident & CAPA, OOS & trending of water reports.
• Responsible for Investigate all issues with respect with Lab.
• Maintenance of laboratory records & compliance as per regulatory requirement. Understands and complies with SOPs, Environmental, Health, Safety, and Quality requirements and applicable regulations.
• Monitor sampling and testing as required for environmental and personnel monitoring, samples of raw materials, in-process product, and finished product.
• Monitor sampling and testing as required for monitoring of critical systems; Purified Water, RO water, Clean Steam, Clean Compressed Air, etc.
• Monitor testing apparatus, solutions, media, cultures, and reagents as required.
• Monitor quantitative and qualitative microbiological tests such as for media controls, enumeration, sterility testing, absence of index organisms, classification and speciation, antimicrobial effectiveness, etc. performed by all QC Microbiology personnel.
• Trains and qualifies personnel for Aseptic Operations, Microbiological Sampling and Testing and associated documentation. Trains Microbiologists, assigns tasks, monitors their performance, and reviews their testing and documentation.
• Monitor calibration checks and performance checks of instrumentation and devices such as TOC, incubators, autoclave, pH meters, balances and refrigerators.
• Reports out of specification results to the Quality Control Director as required under established procedures.
• Provides support for all testing, tasks, and documentation in support of Validation Studies including Process Validation, Media Fills, Method Validation, and development of analytical methods.
• Knowledge of Regulatory audits like : EU GMP, USFDA, ISO 9001 ISO 13485, ISO 22000, Local FDA, WHO
Send your CV to : email@example.com
Last Date : 10th September, 2023
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