CSV Engineer (SAP HANA)

Role Overview: As a Computer System Validation (CSV) Engineer specializing in SAP HANA/S/4HANA validation at a prestigious MNC Pharma company in Mumbai, your primary responsibility will be to develop and oversee CSV deliverables, including VP, URS, FRA, IQ/OQ/PQ, etc. It is crucial to ensure compliance with regulatory standards such as 21 CFR Part 11, EU Annex 11, and GAMP 5. Collaboration with various teams such as QA, IT, and BPOs will be a vital aspect of your role. Additionally, you will be involved in managing SAP system upgrades, patches, and audits as part of your daily tasks. Key Responsibilities: - Develop and oversee CSV deliverables like VP, URS, FRA, IQ/OQ/PQ, etc. - Ensure compliance with regulatory standards such as 21 CFR Part 11, EU Annex 11, and GAMP 5. - Collaborate with QA, IT, and BPO teams. - Manage SAP system upgrades, patches, and audits. Qualifications Required: - Bachelor's degree in Computer Science, Engineering, or Life Sciences. - Minimum of 3 years of experience in CSV within regulated industries. - Proficiency in GxP, ALCOA+, and data integrity standards. - SAP HANA Certification and experience in audit trails, security roles, EDMS/QMS preferred. Note: This is a full-time position based in Mumbai. To apply, please send your CV to ankur.tiwari@ics-india.co.in or contact +91 9109188512. Join the team and contribute to the global pharmaceutical innovation journey.,