13 Aug
|
Xinthe Technologies
|
Hyderabad
13 Aug
Xinthe Technologies
Hyderabad
The IT Project Manager is responsible for end-to-end delivery of GPM application, data, and integration initiatives, including sustainability/modularization efforts, technical remediation, production releases, webservices, and data archiving.
Key Responsibilities:
planning and execution of GPM projects across the full SDLC in accordance with GxP and SDLC governance requirements.
GPM sustainability and modularization efforts to improve long-term maintainability and speed to market.
Partner with Quality and Compliance teams to ensure releases meet 21 CFR Part 11 requirements (electronic records, audit trails, access controls).
Ensure integrations and webservices comply with GxP data integrity, security, and traceability requirements.
Delivery of GPM initiatives in compliance with GxP regulations, including 21 CFR Part 11, data integrity, validation, and audit-readiness expectations.
Support regulated settings by embedding quality, validation, and compliance controls across application, data, and integration initiatives.
Maintain integrated project plans, RAID logs, and milestone tracking.
data archiving initiatives align with GxP records retention, data integrity, and regulatory requirements.
Manage cross-team impacts related to data changes, archiving, and system upgrades.
Lead governance cadence, decision forums, and stakeholder communications.
Required Skills Experience (Enhanced)
Experience managing IT projects in GxP-regulated environments (pharma, biotech, life sciences, or regulated manufacturing).
Working knowledge of 21 CFR Part 11, SDLC controls, validation lifecycle, and audit expectations.
Robust understanding of data integrity principles (ALCOA+), records retention, and compliant data archiving.
Experience operating within controlled change management and validation governance frameworks.
Valuable-to-Have Skills
Experience in Life Sciences, Pharma, or Manufacturing sectors.
Exposure to global vendor management and offshore delivery models.
Understanding of data migration, integration, and scheduling algorithms.
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📌 Gxp It Project Manager Hyderabad
🏢 Xinthe Technologies
📍 Hyderabad