At Sun Pharma, we commit to helping you “Create your own sunshine”— by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.
Are You Ready to Create Your Own Sunshine?
As you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”
Job Summary:
The job holder will be responsible for managing the Plant GxP Application Inventory and supporting CSV projects as the Technical Owner for Computer System Validation (CSV) documentation related to GxP applications. They will conduct periodic CSV and QMS activities throughout the system lifecycle, from implementation to retirement. Additionally, they will assist the business during internal and external audits by explaining processes and documentation related to CSV and remediation.
Responsibilities:
- To manage the Inventory of GxP Applications for Manufacturing & Quality IT.
- To support the Planning and review of validation deliverables for CSV Projects.
- Support in Preparation, reviews and Approval of Computer System Validation (CSV) documents as per implemented processes 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.
- Detailed understanding for 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 IT CSV Documents.
- 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.)
