Plant Engineer L2

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.