VIRBHADRA INDE
Bangalore
Summary
To work, learn and grow with an organization to reach a high level in managerial hierarchy and be instrumental in driving it beyond its mission by adhering to its values and utilizing my potential and talents to its fullest.
Overview
14
14
years of professional experience
Work History
Deputy Manager CQA
Biocon Limited
08.2023 - Current
- Currently am responsible for CSV/CSA and ITQA Project Management activities and e-compliance with handling QMS Management for Corporate Applications and computerized systems of Manufacturing equipment's which are applicable for Formulation and API sites of Biocon for applications such as, Trackwise, DMS, LIMS, SAP-ATTP, vLMS, SAP-SF etc
- Successfully Implemented Serialization for China, US, ROW markets in SAP-ATTP system
- Successfully Implemented Valgenesis-Validation Life Cycle Management
- Routine activities such as Onboarding Qualification/Validation of Customers in serialization(SAP-ATTP)
- VLMS Upgradations and routine change requirements validation.
Assistant Manager-CSV\ITQA Compliance
Dr. Reddy's Laboratories Ltd
08.2021 - 07.2023
- Handled CSV Validation and routine monitoring such as Audit Trails and Periodic Review and QMS activities for EMS, BMS, MES (Rockwell Automation), L2 (HMI-Historian) and Computerized systems of manufacturing, packaging equipment's
- S4-HANA (SAP), WMS, Dochub, Valgenesis (CSV-Validation tool) and Track-Trace for Pharmaceuticals
- Performed Internal Audits, Self-Inspection and Compliance Tracking as per Corporate Procedures
- Preparation of CSV Deliverables URS, CS, FS, IQ, OQ, PQ and testing in Valgenesis, handling of defects, incidents, deviation, and change management for CSV projects.
Assistant Manager-Quality Assurance
CIPLA Limited
01.2021 - 08.2021
- Handling of QMS (Quality Management Systems) and Equipment Qualification/Computerized System Validation for Solid Oral Dosage Forms
- Review And Assignment of Change Controls, Change Actions, Risk Assessment, Risk Management etc
- CAPA Management, IT Tickets Management in SAP.
Sr.Executive QA- QMS
Sun Pharma Ltd
12.2019 - 01.2021
- QMS (Change Control, CAPA, Market Complaint, APQR) Equipment Qualification and Computerized System Validation.
Executive QA-IPQA\ QMS
Lupin Limited
12.2014 - 12.2019
- Handled IPQA activities followed by leading the IPQA Team and QMS, Equipment Qualification Activities
- Review And Approval of Batch Manufacturing Records, Batch Release etc
- Handled Process Validation of Products, Equipment Qualification Activities.
Executive QA-IPQA
Glenmark Generics Ltd
08.2013 - 12.2014
- Shop-floor Quality Assurance, GxP Compliance
- Monitoring of Manufacturing and Packing Process in Oral Solid Dosage Form
- IPQA Activities.
Apprentice Production-Packing
Sanofi-Aventis Ltd
10.2010 - 06.2011
- Oversaw resource allocation, innovation strategies and improvement processes focused on eliminating waste, increasing efficiency and revamping workflow
- Collaborated with production team on high quality and timely delivery of products
- Evaluated BMR, BPR production reports to identify concerns and develop corrective solutions.
Education
M.PHARM(Quality Assurance) -
Maharashtra College of Pharmacy Nilanga
B.PHARM -
Maharashtra College of Pharmacy Nilanga
Skills
- Change Management
- CAPA Management
- Computer system validation
- CSV Project Management
- GAMP 5 Knowledge
- Data Integrity Compliance
- Defect/Incident/Deviation Management
- Quality risk management
- Standard Operating Procedures
- Audit and Inspection Readiness
- Excellent Communication
- Organizational Skills
- Regulatory Compliance
Languages
English
Hindi
Marathi
Kannada
Personal Information
- Father's Name: Inde Virpakshappa Virbhadrappa
- Date of Birth: 07/15/89
- Gender: Male
- Marital Status: Married
Timeline
Deputy Manager CQA
Biocon Limited
08.2023 - Current
Assistant Manager-CSV\ITQA Compliance
Dr. Reddy's Laboratories Ltd
08.2021 - 07.2023
Assistant Manager-Quality Assurance
CIPLA Limited
01.2021 - 08.2021
Sr.Executive QA- QMS
Sun Pharma Ltd
12.2019 - 01.2021
Executive QA-IPQA\ QMS
Lupin Limited
12.2014 - 12.2019
Executive QA-IPQA
Glenmark Generics Ltd
08.2013 - 12.2014
Apprentice Production-Packing
Sanofi-Aventis Ltd
10.2010 - 06.2011
M.PHARM(Quality Assurance) -
Maharashtra College of Pharmacy Nilanga
B.PHARM -
Maharashtra College of Pharmacy Nilanga
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