Mahesh Sivayogi
Hyderabad
Summary
Accomplished GxP System Qualification & Compliance professional at Granules India Limited, adept at enhancing system performance and ensuring regulatory compliance. Demonstrated leadership in validation projects and effective communication in cross-functional teams, leveraging critical thinking and expertise in risk assessment to drive continuous improvement in quality systems.
Overview
4
4
years of professional experience
Work History
GxP System Qualification & Compliance
Granules India limited
Hyderabad
12.2022 - Current
- Qualified GxP Systems in alignment with FDA, EU, GMP, and other relevant regulatory requirements to ensure full compliance
- Upgraded GxP Systems according to regulatory standards, enhancing system performance and ensuring ongoing compliance with global guidelines
- Installed new systems and equipment in regulated environments, ensuring compliance with GxP, FDA, and industry standards
- Led validation projects ensuring compliance with key regulations such as 21 CFR Part 11, Annex 11, and GAMP 5 during system lifecycle phases
- Conducted risk assessments to identify compliance gaps in computerized systems, implementing corrective actions and mitigation strategies
- Prepared and reviewed SDLC deliverables- URS, VP, Specifications (FS, DS, CS), Risk Assessments (IRA, FRA), qualification (IQ, OQ, PQ), Traceability Matrix (TM), Validation Summary Report, and Test Summary Report
- Coordinated the preparation and review of System Specifications (URS, FS, DS, CS), ensuring alignment with both regulatory requirements and business needs
- Processed SDLC documents for stakeholder approvals, including Process Owners, System Owners, and Quality Administrators, ensuring all documentation meets required compliance standards
- Expertise in manual testing, ensuring the proper execution of qualification protocols (IQ, OQ, PQ) and providing detailed reports on test results
- Contributed to test estimation and strategy implementation, optimizing testing efforts and ensuring alignment with project timelines and regulatory requirements
- Executed and documented System Integration Testing (SIT) and User Acceptance Testing (UAT), verifying system performance, functionality, and compliance with user requirements
- Ensured data integrity by applying best practices in electronic records and signatures management, in compliance with 21 CFR Part 11 and Annex 11
- Collaborated with cross-functional teams (IT, Quality, Manufacturing) to evaluate and implement corrective actions for non-compliance issues
- Utilized validation tools and automation to streamline testing, reduce manual errors, and improve efficiency throughout the qualification process
- Collaborated with IT and Quality Assurance teams to ensure systems are maintained properly and corrective actions are implemented to address any compliance issues
- Resolved discrepancies -By conducting root cause, seeking input from the SME and implementing corrective action to resolve the issue
- Valgensis tool - For Electronic validation
- FMEA Tool - For Risk Assessment
- QC System: Qualification of the software - AAS, FTIR, TOC, TIAMO, Melting Point, Magellan, PAMAS, Chromeleon
- Production: HPHV(Autoclave), (JUMO & ZENON), Offline NVPC
- Microbiology: Vitek 2 compact system
- PLC with SCADA and HMI System
QC Senior Executive
Lazuline Biotech private limited
Hyderabad
05.2022 - 12.2022
- Calibration of all QC instruments.
- Maintain good laboratory practices.
- Review of all analytical documents.
- Working standard qualifications.
- Handling of HPLC troubleshooting.
- Handling of all QMS-related activities, like OOS, OOT, change controls, and deviations.
- Handled HPLC instruments (Shimadzu AHT, CHT 2010, Agilent, I Prominence), supported by Chromeleon 7.2 and Empower 3.
QC Executive
Shilpa Medicare limited
Hyderabad
06.2021 - 03.2022
- Calibration of all QC instruments.
- Maintain good laboratory practices.
- Routine analysis (assay, dissolution, RS).
- Working standard qualifications.
- Handling of HPLC troubleshooting.
- Handling of all QMS-related activities, like OOS, OOT, change controls, and deviations.
Education
B. Pharmacy - B. Pharmacy
Rao's Collage of Pharmacy
Nellore06-2015
Skills
- Microsoft 365
- Project Management
- Teamwork
- Time management
- Leadership
- Effective communication
- Critical Thinking
Validations Expertise
- QC System: Qualification of the software - AAS, FTIR, TOC, TIAMO, Melting Point, Magellan, PAMAS, Chromeleon.
- Production: HPHV(Autoclave), (JUMO & ZENON), Offline NVPC.
- Microbiology: Vitek 2 compact system.
- PLC with SCADA and HMI System.
Applicant Signature
Mahesh Sivayogi
Languages
- English
- Telugu
Disclaimer
I undersigned candidate Sakshi Sharma, declare that above information is true and correct to the best of my knowledge and brief.
Tools And Techniques
- Valgensis tool - For Electronic validation.
- FMEA Tool - For Risk Assessment.
Personal Information
- Father's Name: Sivayogi Janardana
- Mother's Name: Sivayogi Jamuna
- Date of Birth: 23/05/1994
- Marital Status: Married
Languages
Telugu
First Language
English
Advanced (C1)
C1
Timeline
GxP System Qualification & Compliance
Granules India limited
12.2022 - Current
QC Senior Executive
Lazuline Biotech private limited
05.2022 - 12.2022
QC Executive
Shilpa Medicare limited
06.2021 - 03.2022
B. Pharmacy - B. Pharmacy
Rao's Collage of Pharmacy
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