
Hareesh Rao
Megsan Labs Pvt Ltd : Responsible for review of Analytical method validations, Analytical Method Verifications... | Ulhasnagar, Ulhasnagar, India
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Hareesh Rao’s Emails ha****@bh****.com
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Hareesh Rao’s Location Ulhasnagar, Ulhasnagar, India
Hareesh Rao’s Expertise Megsan Labs Pvt Ltd : Responsible for review of Analytical method validations, Analytical Method Verifications & Method developments related to Microbiology i.e., Microbial Limit Test (MLT), Sterility Test (ST), Antimicrobial Effectiveness Test (AET), Bacterial Endotoxin Test (BET). Responsible for review and release of Batch Reports and Environmental Monitoring Reports through LIMS. Responsible for review of documents i.e., Area Qualification, Autoclave validations. Calibration and maintenance status of all instruments and its completion in timelines against in Master calibration schedule. Responsible for preparation, periodic review Revision and implementation of SOPs. Responsible for initiating & effective closures of QMS documents like Deviations, Change controls, Incidents and CAPA. Responsible for conducting and monitoring of Internal Audits/ Self inspections. Responsible for compliance & implementation of Regulatory policies and procedures. To maintain Good Laboratory Practices in the laboratory, daily monitoring of activities performed by the analysts. Responsible for ensuring the Qualification of Equipments. Preparation of Master calibration schedule, monitoring, and verification of logbooks. Coordinating, imparting, and facilitating cGMP related trainings for department employees and new recruits. To prepare and maintain annual training matrix for department. Preparation of Organogram and verification of training related records for ensuring compliance. Faced the USFDA, NABL & CUSTOMER Audits. Vendor Management. Document Control, Issuance, Retrieval, and archival activity. Bharat Serums & Vaccines Limited: Responsible for conducting Study based audits, Process based audits & Facility based inspections. Assess the quality of all reports to ensure they are incompliance with GLP principles. Responsible for availability of QA statement and details of inspections in the GLP reports. Responsible for the review of QC Batch Reports (Toxicity, Hormone Bioassays & ED50 Venom). Responsible for the preparation and review of Standard Operating Procedures. Vendor Management. Responsible for ensuring the Qualification of Equipments. Responsible for ensuring GMP & GLP compliance with respect to the guidelines. Responsible to provide trainings to all employees. Responsible to coordinate Regulatory bodies, audit reports and closures follow-ups. Faced the WHO, GLP & CUSTOMER Audits.
Hareesh Rao’s Current Industry Bharat Serums And Vaccines
Hareesh
Rao’s Prior Industry
Megsan Labs
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Bharat Serums And Vaccines
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Work Experience

Bharat Serums And Vaccines
Assistant Manager QA
Wed Dec 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Megsan Labs
Officer
Fri Apr 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Thu Jul 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time)