Website HiMedia Laboratories
About HiMedia Laboratories
HiMedia Laboratories Private Limited is a prominent bioscience company with its origins in India, headquartered in Mumbai, Maharashtra. Founded 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, the company has grown to become a significant player in the Indian biosciences sector.
Today, HiMedia Laboratories is actively involved in the development, manufacturing, and global distribution of a wide range of bioscience-based products. Its influence extends worldwide, and to facilitate its international reach, the company has set up offices and warehouses in Europe and the USA, solidifying its presence on a global scale
Post:
Assistant / Deputy Manager Microbiologist QC / QA
Qualification Required at HiMedia Laboratories:
M.Sc in Microbiologist
Experience Required at HiMedia Laboratories:
10-15 Years
Software Knowledge:
MS Office, SAP (Preferred)
Location:
Palkhed, Nasik
Key Roles and Responsibilities:
1. Development and Implementation of Microbiology Laboratory Manual
- Create and establish comprehensive microbiology laboratory protocols.
2. Inventory Maintenance for Microbiology Laboratory
- Manage and organize inventory within the Microbiology Laboratory.
3. Continuous Knowledge Upgradation
- Stay updated with the latest industry guidelines and information.
4. Water System Knowledge and Testing
- Understand and perform water system testing in compliance with regulatory guidelines.
5. Knowledge of QMS System
- Familiarity with Quality Management System processes such as change control, deviation, incident & CAPA, OOS & water report trending.
6. Issue Investigation
- Take responsibility for investigating laboratory-related issues.
7. Records Maintenance and Regulatory Compliance
- Maintain laboratory records and ensure compliance with regulatory requirements.
8. Monitoring of Sampling and Testing
- Oversee sampling and testing procedures for environmental and personnel monitoring, raw materials, in-process and finished products.
9. Critical Systems Monitoring
- Monitor sampling and testing for critical systems like Purified Water, RO water, Clean Steam, Clean Compressed Air, etc.
10. Apparatus and Solution Monitoring – Ensure testing apparatus, solutions, media, cultures, and reagents are in optimal condition.
11. Qualitative and Quantitative Microbiological Tests – Supervise various microbiological tests including media controls, enumeration, sterility testing, index organism absence, classification and speciation, antimicrobial effectiveness, etc.
12. Personnel Training and Performance – Train and qualify personnel for Aseptic Operations, Microbiological Sampling and Testing. Monitor and review their performance.
13. Instrumentation and Device Monitoring – Monitor calibration and performance checks for instrumentation and devices such as TOC analyzers, incubators, autoclaves, pH meters, balances, and refrigerators.
14. Out of Specification Reporting – Report any out of specification results to the Quality Control Director according to established procedures.
15. Support for Validation Studies – Assist in testing, tasks, and documentation related to Validation Studies including Process Validation, Media Fills, Method Validation, and analytical method development.
16. Knowledge of Regulatory Audits – Familiarity with various regulatory audits such as EU GMP, USFDA, ISO 9001, ISO 13485, ISO 22000, Local FDA, WHO.
Send Your CV to: vsalvi@himedialabs.com
Last Date: 10th September 2023
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To apply for this job email your details to vsalvi@himedialabs.com