Posted:2 weeks ago|
Platform:
On-site
Full Time
The QC Microbiology Manager contributes to proper control of all aspects of the New Vision manufacturing facility that may impact microbiological quality including; manufacturing processes and equipment, materials utilized, physical facilities, environmental conditions, specifications, cleaning and sanitization, sampling and testing, employees, personnel practices and procedures, etc. Must maintain proficiency in all Microbiology laboratory methods, processes, and procedures. Understands and complies with SOPs, Environmental, Health, Safety, and Quality requirements and applicable regulations. Maintains awareness of industry best practices. 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, 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. Reviews Laboratory Notebooks and Logs as detailed in applicable procedures. Produces periodic reports for tracking, evaluation of trends, associated metrics, etc. Monitor calibration checks and performance checks of instrumentation and devices such as RCS, pH meters, balances and refrigerators. Provides support of product development projects, investigations, monitoring of utilities systems, and the stability program. 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.
Job Type: Full-time
Pay: Up to ₹70,000.00 per month
Ability to commute/relocate:
Education:
Experience:
Work Location: In person
Cultivator Group
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