Gaurav Baldaniya
Present Experience Summary : ● Overall 8+ years of experience in Computerized Systems Validation of Enterprise Computerized Systems, Standalone... | Bengaluru, Karnataka, India
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Gaurav Baldaniya’s Emails ba****@li****.com
Gaurav Baldaniya’s Phone Numbers No phone number available.
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Gaurav Baldaniya’s Location Bengaluru, Karnataka, India
Gaurav Baldaniya’s Expertise Present Experience Summary : ● Overall 8+ years of experience in Computerized Systems Validation of Enterprise Computerized Systems, Standalone Computerized Systems, Automated Process control systems, CDS & Excel sheets,ensure regulatory compliance as per 21 CFR Part 11, Annex11, GAMP5 and other guidelines. ● Currently working in Eli Lilly, Bangalore, India since Jan-2021 ● Acting as a Project Quality Manager, PQM (Computer System Validation & compliance, perform Risk Assessments and Functional review of Change controls, implementation of site specific new computerized system and enhancements/modifications, authoring Validation Plan and Validation Report, reviewing other computer system life cycle validation documents) Skills & Responsibilities : ● Good Exposure on Regulatory requirements of Computerized Systems and sound knowledge of GxP, GAMP, EU Annex 11 and USFDA 21 CFR Part 11, 210 and 211. ● Versatile hands on Expertise in Computerized System Validation on all varieties of Computerized Systems which includes, but not limited to Enterprise Computerized Systems, laboratory Standalone Computerized Systems, Automated Process control systems, CDS and Excel sheets. ● Good knowledge on Preparation, review and ensure compliance of Corporate CSVMP, Project Validation Plan, Corporate & site specific Policies and Procedures. ● Hands on experience in preparation of protocols &reports for IQ, OQ, PQ & RQ, other validation deliverables (URS, Gap Assessment, Risk Assessment, Compliance Report, Traceability Matrix, Summary report and interim reports etc.).
Gaurav Baldaniya’s Current Industry Eli Lilly
Gaurav
Baldaniya’s Prior Industry
Anthem Gxp Solutions
|
Mylan Laboratories
|
Novo Nordisk
|
Infosys
|
Eli Lilly
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Work Experience
Eli Lilly
Consultant I - Quality
Wed Mar 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Eli Lilly
Sr Associate Manager - It Solutions
Fri Jan 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Wed Mar 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Infosys
Project Quality Manager At Novartis Pharma Ag
Thu Nov 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Jan 01 2021 00:00:00 GMT+0000 (Coordinated Universal Time)
Novo Nordisk
Associate Business Analyst
Sat Jul 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Oct 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Mylan Laboratories
Senior Associate - Csv
Tue Mar 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Jul 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Anthem Gxp Solutions
Project Engineer
Fri Aug 01 2014 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Feb 01 2016 00:00:00 GMT+0000 (Coordinated Universal Time)Skills
Languages
Gaurav Baldaniya Email Addresses
FAQ About Gaurav Baldaniya
-
Gaurav Baldaniya is located at
Bengaluru, Karnataka, India -
Gaurav Baldaniya is a
Present Experience Summary : ● Overall 8+ years of experience in Computerized Systems Validation of Enterprise Computerized Systems, Standalone Computerized Systems, Automated Process control systems, CDS & Excel sheets,ensure regulatory compliance as per 21 CFR Part 11, Annex11, GAMP5 and other guidelines. ● Currently working in Eli Lilly, Bangalore, India since Jan-2021 ● Acting as a Project Quality Manager, PQM (Computer System Validation & compliance, perform Risk Assessments and Functional review of Change controls, implementation of site specific new computerized system and enhancements/modifications, authoring Validation Plan and Validation Report, reviewing other computer system life cycle validation documents) Skills & Responsibilities : ● Good Exposure on Regulatory requirements of Computerized Systems and sound knowledge of GxP, GAMP, EU Annex 11 and USFDA 21 CFR Part 11, 210 and 211. ● Versatile hands on Expertise in Computerized System Validation on all varieties of Computerized Systems which includes, but not limited to Enterprise Computerized Systems, laboratory Standalone Computerized Systems, Automated Process control systems, CDS and Excel sheets. ● Good knowledge on Preparation, review and ensure compliance of Corporate CSVMP, Project Validation Plan, Corporate & site specific Policies and Procedures. ● Hands on experience in preparation of protocols &reports for IQ, OQ, PQ & RQ, other validation deliverables (URS, Gap Assessment, Risk Assessment, Compliance Report, Traceability Matrix, Summary report and interim reports etc.). Eli Lilly -
Gaurav Baldaniya currently works in the
Eli Lilly -
Gaurav Baldaniya specializes in
Present Experience Summary : ● Overall 8+ years of experience in Computerized Systems Validation of Enterprise Computerized Systems, Standalone Computerized Systems, Automated Process control systems, CDS & Excel sheets,ensure regulatory compliance as per 21 CFR Part 11, Annex11, GAMP5 and other guidelines. ● Currently working in Eli Lilly, Bangalore, India since Jan-2021 ● Acting as a Project Quality Manager, PQM (Computer System Validation & compliance, perform Risk Assessments and Functional review of Change controls, implementation of site specific new computerized system and enhancements/modifications, authoring Validation Plan and Validation Report, reviewing other computer system life cycle validation documents) Skills & Responsibilities : ● Good Exposure on Regulatory requirements of Computerized Systems and sound knowledge of GxP, GAMP, EU Annex 11 and USFDA 21 CFR Part 11, 210 and 211. ● Versatile hands on Expertise in Computerized System Validation on all varieties of Computerized Systems which includes, but not limited to Enterprise Computerized Systems, laboratory Standalone Computerized Systems, Automated Process control systems, CDS and Excel sheets. ● Good knowledge on Preparation, review and ensure compliance of Corporate CSVMP, Project Validation Plan, Corporate & site specific Policies and Procedures. ● Hands on experience in preparation of protocols &reports for IQ, OQ, PQ & RQ, other validation deliverables (URS, Gap Assessment, Risk Assessment, Compliance Report, Traceability Matrix, Summary report and interim reports etc.). -
Gaurav Baldaniya speaks the following languages:
No languages available. -
Gaurav Baldaniya has prior experience in the following industries:
Eli Lilly , Infosys , Novo Nordisk , Mylan Laboratories , Anthem Gxp Solutions -
Gaurav Baldaniya has the following professional experience:
Eli Lilly , Eli Lilly , Infosys , Novo Nordisk , Mylan Laboratories , Anthem Gxp Solutions . -
You can view Gaurav Baldaniya’s
LinkedIn profile at LinkedIn URL. -
Gaurav Baldaniya’s work email addresses are
[email protected] . -
Gaurav Baldaniya works at
Eli Lilly
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