Officer/Sr. Officer/Executive/Sr. Executive(Quality Control)

2 - 8 years

0 Lacs

Posted:3 days ago| Platform: Shine logo

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Work Mode

On-site

Job Type

Full Time

Job Description

As an Officer/Sr. Officer/Executive/Sr. Executive in the company, your role will involve the following key responsibilities: - Daily sampling and analysis of in-process and water samples as per procedure - Preparation and pouring of media plate - Performing BET (Bacterial Endotoxin Test) test and Micro assay - Conducting Sterility Test, Bioburden, and MLT (Microbial Limit Test) for water and product - Performing Growth Promotion / Inhibitory / Indicative Property Test of Media - Reporting results of analysis in raw data sheet issued - Entry and maintenance of all micro related logbooks - Following the QMS (Quality Management System) system (Out of Specification, Deviation, Incident) - Participating in validation activities - Observing and reviewing media fill container - Conducting environmental monitoring in clean room as per standard operating procedure - Running the autoclave cycles and unloading the loads as per SOP - Monitoring incubator condition daily, recording, taking print out and verifying - Maintaining GLP (Good laboratory practices) and following GDP (Good documentation practices) in the laboratory - Running washing and drying machine - Raising Out of Specification if noticed - Performing analysis of Analytical method Validation, Analytical method Transfer, reconstitute Solution stability, additional analytical test required as per party quarry reply - Preparing Analytical method validation protocol, raw data, report - Reviewing Analytical method validation protocol, raw data, report - Preparing excel sheet for analytical method validation, method transfer, Reconstitute Solution Stability study - Planning method validation activity and providing necessary resources to the analyst - Training analysts for analytical method validation and method transfer SOPs - Controlling and maintaining records like protocols, raw data, and report of method validation, method transfer, and reconstitute solution stability - Assisting HOD (Head of Department) for the preparation of regulatory inspection As per the provided job description, there are no additional details about the company mentioned.,

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