Lifecycle and compliance: Owns the system from implementation to retirement and keeps it validated, documented, and compliant with GxP regulations (GAMP 5, Annex 11, Part 11).
Change control: Governs all changes, upgrades, and releases so nothing reaches production without proper assessment, testing, and approval.
Operations and security: Keeps the system available and secure through incident management, access control, backup and disaster recovery, and patching.
Supplier and stakeholder management: Manages vendors, SLAs, budget, and roadmap, and acts as the main point of contact between business, IT, and QA.
Audit and inspection: Represents the system during audits and inspections and owns any resulting CAPAs.
📌 GxP System Owner / IT System Owner (Pune)
🏢 AmpsTek
📍 Pune
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