M Sreekanth
Hydrabad
Summary
Dynamic IT professional with extensive experience at Biocon Ltd, specializing in software validation and quality risk management. Proven track record in leading digitalization initiatives and ensuring data integrity compliance. Adept at developing validation protocols and collaborating across teams to enhance system performance and support scientific workflows.
Overview
10
10
years of professional experience
Work History
Deputy Manager (IT-Scientific Applications)
Biocon Ltd
Hyderabad
08.2021 - Current
- Managing and operating scientific applications support activities.
- Overseeing the implementation and maintenance of IT systems to ensure data integrity and compliance with regulatory standards.
- Collaborating with cross-functional teams to optimize system performance and support scientific workflows.
- Developed protocols for validating products against internal and industry standards.
- Developed and implemented data migration plans for CSV projects.
- Provided technical support during installation, configuration, and maintenance activities.
- Led audits of various IT systems to confirm accuracy of associated documentation.
- Collaborated with cross-functional teams to ensure successful implementation of CSV initiatives.
- Performed risk assessment activities for computer systems.
Assistant Manager (Digitalization) - Quality Management System, Computer System Validations
HETERO LABS LIMITED
06.2017 - 08.2021
- Led digitalization initiatives within the Quality department, focusing on Quality Management Systems and Computer System Validations.
- Developed and maintained validation documentation, including VMP, URS, FRS, and validation protocols.
- Conducted risk assessments and gap analyses to ensure compliance with regulatory standards.
Senior Executive - Chemical Quality (CQ)
HOSPIRA HEALTHCARE LIMITED (A Pfizer Company)
01.2015 - 05.2017
- Managed chemical quality control processes to ensure product safety and efficacy.
- Conducted routine testing and analysis of chemical samples, adhering to strict quality standards.
- Collaborated with cross-functional teams to resolve quality issues and implement corrective actions.
Education
MBA - IT
Vignan University
Online04.2025
M.Sc. - Organic Chemistry
Osmania University
Hyderabad05-2008
B.Sc. - B.Z.C
Osmania University
Hyderabad04-2006
Skills
- Change control management
- CAPA management
- Quality risk management
- Software validation
- Data integrity compliance
- Hardware validation
- Validation protocol development
- CSV project management
- IQ, OQ, PQ execution
- Test script development
- LABWARE/ Caliber LIMS
- Empower3/Chromeleon/OpenLab CDS
- DMS/ EDMS
- SF LMS/Nichelon
- Track wise/QAMS
- Waters Nugenesis SDMS (As backup tool & Unifi print mode)
Disclaimer
I hereby declare that the above-mentioned particulars are true to the best of my knowledge.
Previous Experience
- Granules India Limited
- Syngene International Limited
Timeline
Deputy Manager (IT-Scientific Applications)
Biocon Ltd
08.2021 - Current
Assistant Manager (Digitalization) - Quality Management System, Computer System Validations
HETERO LABS LIMITED
06.2017 - 08.2021
Senior Executive - Chemical Quality (CQ)
HOSPIRA HEALTHCARE LIMITED (A Pfizer Company)
01.2015 - 05.2017
MBA - IT
Vignan University
M.Sc. - Organic Chemistry
Osmania University
B.Sc. - B.Z.C
Osmania University
Similar Profiles
Satya PatamsettySatya Patamsetty
Associate Manager at BIOCON LTDAssociate Manager at BIOCON LTD
Narasimha PrabhuNarasimha Prabhu
Chemical Engineer With 14 Year Experience at Biocon LtdChemical Engineer With 14 Year Experience at Biocon Ltd
Narasimha Murthy G.M.Narasimha Murthy G.M.
Associate Manager at Biocon LtdAssociate Manager at Biocon Ltd