Senior Officer In Quality Assurance
Current1. PQR and CPV preparation and planning2. Computerized system validation.•Strong knowledge of Software Development Life Cycle (SDLC) methodologies such as Waterfall, V-Model, Spiral, Iterative and Agile.•Computerized System Validation Skills•Good exposure on Life cycle documentation and responsible for tracking, monitoring and controlling validation process to ensure timely and cost-effective delivery of the system to the business users /customers •Responsible for Prepare and/or review all levels of CSV validation documents including: Validation Plans, User Requirement Specifications•Review of High Level risk Assessment includes GxP Assessment and GAMP categorization, criticality Assessment, ERES Applicability Assessment etc. •Definition Documents, including Functional Specifications, Design Specifications or Configuration Documents and SOPs, VMP and VP •Qualification Documents and Test Specifications (DQ, IQ, OQ scripts) •Traceability Matrices, Gap assessments and Risk Analysis •21 CFR Part 11, EU annex 11 assessments for Process systems •Quality Management System.•Provide CSV technical sign-off for all the above •Experience in various Software Development Life Cycle (SDLC), Like Waterfall, V-Model, and Agile methodology.•Expertise in documenting Design Review and Qualification Protocol, Technical Writing. Excellent experience as Validation Specialist and in-depth involvement in writing test scripts for Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ).3. Excel sheet validation preparation of report and protocol and SOP4. Handling of documents5. Handling of artwork, Certificate of analytic (Raw material, packing material and finished goods)6. Manage Regulate documents and issuance and distribution record 7. Progen ERP all Module handling8. Good knowledge of IT infrastructure, network, hardware and software and data backup etc.
