Jayaprakash Kallega
Compliance Lead
About
Expert in leading Computer System Validation, transformation / implementing IT systems including project Management
Extensive experience as a leader in Computer Systems Validation / IT QA with direct management responsibility of cross-functional teams for a broad spectrum IT / computer system elements [software applications including cloud systems, infrastructure, network components], enterprise systems (Lab systems, MES, ERP), manufacturing area and equipment.
Good knowledge in pharmaceutical regulatory compliance for IT (21CFR Part 11, EU Annex 11)
In-Depth knowledge of data integrity principles and ability to assess computer systems
Expertise in conducting risk assessments and knowledgeable in current industry good practice for CSV like GAMP-5
Experience with application of CAPA methodology including a structured approach for failure investigation and identification of root cause (RCA)
Experience in conducting as well as participating in regulatory inspections, presenting/defending IT functions in audits (regulatory inspections/internal audits/external audits)
Experience in conducting/addressing vendor qualification exercises (discovery/RFP and qualification audits/service audits)
Contact Information
Professional Email
****@****.com
Personal Email
****@****.com
Work Phone
(***) ***-***
Mobile
(***) ***-***
Local Location
Bengaluru, Karnataka, India
Website
https://sites.google.com/view/jayaprakashkallega/
Industry
IT Services and IT Consulting
Designation
Compliance Lead
Birthday
-
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