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Senior Manager, CSV IT at Amneal India

Ahmedabad, gujarat, India -

Full Time

Start Date

Immediate

Expiry Date

09 Oct, 26

Salary

0.0

Posted On

11 Jul, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Computer System Validation, GAMP 5, 21 CFR Part 11, EU Annex 11, GxP Compliance, ERP Validation, LIMS, QMS, DMS, LMS, Risk Assessment, Stakeholder Management, Audit Leadership, Team Leadership, Data Integrity, Validation Master Plans

Industry

Pharmaceutical Manufacturing

Description

Key Responsibilities: 1. CSV Strategy & Governance - Develop and maintain the overall CSV strategy and validation master plans for global systems. - Ensure compliance with GAMP 5, USFDA, EU Annex 11, 21 CFR Part 11, and global regulatory requirements. - Establish standardized validation methodologies, templates, SOPs, and best practices. 2. Project & Stakeholder Management - Lead validation planning and execution for enterprise applications including ERP, LIMS, DMS, QMS, LMS, and others. - Collaborate with functional teams, QA, and global stakeholders. - Work with vendors/partners to align on validation scope and deliverables. 3. Validation Execution - Oversee and review CSV documentation: URS, FS, DS, Risk Assessments, IQ/OQ/PQ, Validation Reports, Periodic Reviews. - Ensure traceability and compliance across lifecycle deliverables. - Monitor deviations, CAPAs, and change controls. 4. Audit & Compliance Leadership - Act as the face of IT CSV during internal, external, and regulatory audits (USFDA, MHRA, etc.). - Provide expert guidance on compliance gaps and remediation. - Track industry trends and regulatory updates. 5. Team Leadership - Lead and mentor a team of 4–5 CSV professionals. - Review deliverables and ensure timely completion of activities. - Drive capability building and continuous improvement. Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.

Responsibilities

Develop and maintain the global CSV strategy and validation master plans to ensure compliance with global regulatory requirements. Lead the validation execution for enterprise applications and represent the IT department during regulatory audits.