Validation Lead API; Ahmednagar
Listed on 2026-07-13
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IT/Tech
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Quality Assurance - QA/QC
Job Summary
The job holder will be responsible for managing the Plant GxP Application Inventory and serving as the Technical Owner for Computer System Validation (CSV) documentation related to GxP applications. They will oversee periodic CSV and QMS activities throughout the system lifecycle, from implementation to retirement. Additionally, they will support the business during internal and external audits by explaining processes and documentation related to CSV and remediation.
Responsibilities- To manage Inventory of GxP Applications for Manufacturing & Quality IT.
- Planning and review of validation deliverables for CSV Projects.
- Preparation, reviews and Approval of CSV documents as Technical Owner.
- Ensuring the compliance of GSOP’s /SOP’s related to Computer System Validation documentation and regulatory requirements during execution of CSV Project.
- Understanding the working and usage of Systems such as Trackwise, Validator and EDMS.
- Compliances to IT policies and procedures & regulatory requirements and support for the internal and external audits and remediation.
- Vendor coordination and support during Installation qualification (IQ), Operational qualification & Performance qualification (PQ).
- Identify the continuous improvement opportunities for CSV projects.
- Documentation and control for management of CSV documents w.r.t. IT.
- Timely completion of validation activities with zero timeline extensions
- Full audit readiness with complete and compliant documentation
- Effective and timely closure of all related QMS records (deviations, CAPA, change controls, etc.)
Based on the need job holder can travel to other sites.
Job Scope Internal Interactions (within the organization)System Owners from site Quality & Manufacturing and CQIT, Corporate IT.
External Interactions (outside the organization)Business Users, External Vendors
Geographical ScopeProvide onsite support to the site & other site whenever needed Remotely.
Financial Accountability (cost/revenue with exclusive authority)NA
Job Requirements Educational Qualification- BE/B. Tech, MCA, BCA, MSc IT, BSc. IT, Graduation + PGDCA.
NA
Skills- Computer System Validation, Understanding of IT regulatory requirements, Execution of Validation & Qualification activities.
8-10 Years in IT activities preferably in Pharma Manufacturing.
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