Arushi Kukreja
Associate Director - Talent Acquisition at eli lilly and company
pharmaceutical manufacturing
Gurgaon, Haryana, India
Gaurav Baldaniya
Consultant I - Quality
About
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.).
Contact Information
Professional Email
****@****.com
Personal Email
gba****@gmail.com
Work Phone
(***) ***-***
Mobile
(***) ***-***
Local Location
Bengaluru, Karnataka, India
HQ Location
indianapolis, indiana, united states
Industry
Pharmaceutical Manufacturing
Designation
Consultant I - Quality
Birthday
October 10
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HQ Location
indianapolis, indiana, united states
Industry
pharmaceutical manufacturing
Employees
53318
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