Abilash Bijjala
Quality & Compliance | Supplier Qualification | Audit & Inspection Management | CSV & Infrastructure Qualification | Data Integrity Expert
- Role
- Associate Director, IT Quality & Compliance at Gilead Sciences
- Location
- San Francisco, CA, US
- LinkedIn followers
- 500 followers
About Abilash Bijjala
Strong experience in the GxP world with emphasis on the Computer System Validation and Infrastructure Qualification. Good understanding & implementation knowledge of FDA 21 CFR Part 11, EU Annex 11, ICH, GAMP 5 guidelines, and GxPs (GMP, GCP, GLP) regulations. Played various roles including but not limited to Business Analyst, Validation Engineer and Quality Assurance in the Life sciences industry. Skilled in Change Control, CAPA, Deviation Management, Inspection Management, Risk based Validation, Data Integrity, Auditing, Technical writing and Process improvement.
Experience
Associate Director, IT Quality & Compliance
Mar 2023 — Present · Foster City, CA, US
Education
SRM IST Chennai
Bachelor of Technology (B.Tech.), Biotechnology
Louisiana Tech University
Master of Science (MS), Nanotechnology
Skills
- Validation
- 21 Cfr Part 11
- Quality Assurance
- Risk Management
- Computer System Validation
- Infrastructure Qualification
- Gxp
- Technical Writing
- Capa
- Deviation Management
- Change Management
- Fda
- Pharmaceutical Industry
- Eu Annex 11
- Gamp
- Regulatory Compliance
- Erp
- Oracle Applications
- Trackwise
- Documentum
- Auditing
- Process Improvement
- Testing
- Hp Quality Center
- Ich Guidelines
- Fmea
- Life Sciences
- Root Cause Analysis
- Sop
- Requirement Engineering
- Sharepoint
- Oracle Fusion Middleware
- Standard Operating Procedure (Sop)
- U.s. Food and Drug Administration (Fda)
- U.s. Title 21 Cfr Part 11 Regulation
- Gmp
- Corrective and Preventive Action (Capa)
- Change Control
- Active Directory
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