Job Description

Product Validation ~Documentation Control ~Equipment Validation & Qualification ~Product Lifecycle Management ~Defect Management ~Project Handling Expertise Knowledge of FDA regulations, EU guidelines, CSV, GAMP guidelines and product development process. Ensuring the quality compliance with respective areas and GxP guidelines. Significant exposure in maintaining & ensuring stringent adherence to quality, identifying gaps, norms & practices. Abilities to understand their requirement related to product they need and deliverables. Abilities in implementing quality plans with focus on identifying gaps. Key result Areas: Execution and compliation of CSV Qualifications for all the GxP applications in Manufacturing area. Execution of Qualification activities IQ, OQ, PQ for all GxP systems in the manufacturing process equipments. Administration and User Management of all the laboratory applications, Instruments, Manufacturing process Equipments as per SOP. Vendor co-ordination for all the IT related news projects and requirements. Co-ordination with CFT's for qualification document approvals. Performing the User ID Role Matrix, Manual Backup periodic activity as per SOP. Ensuring that validation activities align with relevant regulations such as FDA 21 CFR Part 11, EU Annex 11, and other applicable guidelines. Ensuring all documentation aligns with regulatory expectations and internal quality standards. Responsible for curation and review of quality and validation documents with assurance of GxP compliance, adherence to safety polices. Responsible for knowledge sharing to new joiners on projects and standard operating procedure. Responsible for putting ideas and suggestions to teams with respect to process & projects.