Sanjay Vyas

About Sanjay Vyas

Proven, solutions-driven professional with 26 years of experience leading quality…

Experience

1. Quality Assurance Manager

   GSK

   Aug 2008 — Present · US

   Being a Batch Release Officer/Subject Matter Expert for Secondary Pilot plant, I work on Pre-review/Post review of the batch records, makes go/no-go decisions for manufacturing activities, Issue Observation report and provide feedback for the observation response, technical approval of batch in COMET, GMS batch release, Dose on demand batch release including primary and secondary batch technical and regulatory release. I have worked and trained four personal on review/approval of Distribution risk assessment and QA activation of Shelf-life in COMET and review of shelf life justification/DRA. I am also an SME for all US Extemporaneous compounding release. I have worked Technical terms of supply review/approval, SOP/EOP review/approval.I am Quality Alert communicator for the UM/UP site quality Alerts. I am working on Pre Approval Inspection readiness data integrity audits of PHI drug product.I am member of batch record COP, Syncade COP and Extemporaneous compounding Community of practice and provided required in-put regarding PSQA questions. I have worked on review/approval of Deviations, Customer/vendor complaint.I have worked on review/approval of clinical site temperature excursionI have performed L1 audits every year and participated in at lease one L2 audit every year and written the Findings, which were acceptable to manager of IBM group.I have worked on Process/Facility/laboratory change controls Pre/post review/approval. I have approved all process change controls for UP site. I have approved Periodic Validation Review\'s and provide pre/post review of Facility change controls of Stability change controls. I have approved Pre/post change controls for various laboratory equipment\'s including HPLC and KF moisture analyzer.

Education

• Vocational School

  Certification, Pharmacy Technician

  1994 — 1994

• Gujarat University

  Bachelor, Chemistry/ Physics

  1980 — 1984

Skills

• U.s. Food and Drug Administration (Fda)
• Corrective and Preventive Action (Capa)
• Software Documentation
• Quality Assurance
• Validation
• Management
• Sop
• Fda
• Capa
• Quality System
• V&V
• Regulatory Affairs
• Quality Control
• Gmp
• Standard Operating Procedure (Sop)
• Glp
• Verification and Validation (V&V)
• Change Control
• 21 Cfr Part 11
• Gxp