Title- Validation Lead Experience- 10+ Location- Thousand oaks, CA Job description:
Hands on experience in Authoring and Reviewing IS Deliverables Validation Plan, Requirements Specifications, Requirement Traceability Matrix, Qualification Testing (QT) Pre-& Post Approval Protocols, Installation Testing (IQ) Pre-& Post Approval Protocols and Validation Summary Report
Well versed with Change Management process, systems and Document Management System
Good understanding of all Standard Operating Procedures (SOP) related to GMP business processes
Extensive experience in handling Validation of GMP Business Systems dictated by the Code of Federal Regulations, Title 21 CFR Part 11 and the European Union’s Annex 11
Experienced in handling Waterfall, Agile Scrum, Hybrid Scrum, CDF (A DevOps methodology) and Lean Sig Sigma SDLC methodologies
Thanks & Regards, Tejas Vyas Team Lead- Recruitment Ascii Group LLC
