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Candidate should have experience in quality management system, compliance, regulatory inspection, sterile manufacturing, failure investigation, drafting, and reviewing.

Handling of EM team and monitor the execution of EM and water sampling as per schedule. Responsible for preparation and review of protocols, SOPs, trends, sampling plans, and reports related to environmental monitoring studies and qualifications. Also involved in the qualification of analysts and handling investigations of OOL, OOS, and others. Commitment to diversity, equity, and inclusion is a core value at the company.

Candidate should have knowledge for handling of manufacturing line and capable to lead a team. Candidate should have knowledge about Media fill simulation cleaning validation. He should capable to implementation of sterility assurance governance programme. He should be able to investigate deviations, OOS, OOL related to Microbiology investigations. Candidate should be capable to Conduct Internal Audits. Candidate should be capable to prepare and review SOP and Batch records. He should have effective written and verbal communication and interpersonal skills.

Analyst required for testing of Raw material, Packing Material, and Water. Responsibilities include conducting chemical analysis, using instruments like HPLC, GC, FTIR, DSC, and Autotitrator, performing audits, and ensuring data integrity. Good communication and documentation skills are essential.

Responsible for vendor qualification, audit, and maintaining documents for vendors. Performing vendor audits, monitoring regulatory compliance, and supporting lead auditor. Handling QMS in Trackwise and documentation in Master control. Minimum Bachelor degree required with hands-on experience in sterile vendor qualification in GMP environment.

Responsible for reviewing microbiological documents, ensuring compliance with SOP and cGMP requirements, and providing technical support for the analytical laboratory. Maintain good documentation practices and support QMS activities. M.Sc. Microbiology degree with 3-8 years of experience required.

Develop robust analytical methods, perform routine and stability sample analysis for injectable products, assist in day-to-day lab operations, support method transfer to manufacturing units, and conduct routine analysis.