JOB DETAILS

Senior Manager, CSV IT

CompanyAmneal India
LocationAhmedabad
Work ModeOn Site
PostedJuly 11, 2026
About The Company
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) is guided by a simple belief: essential medicines should be accessible to everyone. What began as a promise to deliver high-quality, affordable medicines has evolved into a diversified portfolio spanning complex generics and injectables, biosimilars, and specialty medicines, including more than 290 products, with scale and capabilities that help reach patients across the healthcare system while combining world-class precision with a deep sense of personal responsibility for every dose we deliver. Content is for informational purposes only and 3rd party content does not reflect Amneal’s opinions. Amneal has the right to remove comments that violate another’s copyright or intellectual property, mention an Amneal product, use profanity or are defamatory, promote and solicit for third-party sites, initiatives, or products, or are factually inaccurate or misleading or spam. Amneal recommends that you consult with your healthcare provider regarding personal health matters. To report a product complaint or adverse event related to an Amneal product, contact Drug Safety at 877-835-5472, option 3 or drugsafety@amneal.com. If you are currently experiencing a life-threatening event, please immediately contact 911.
About the Role

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.
Key Skills
Computer System ValidationGAMP 521 CFR Part 11EU Annex 11GxP ComplianceERP ValidationLIMSQMSDMSLMSRisk AssessmentStakeholder ManagementAudit LeadershipTeam LeadershipData IntegrityValidation Master Plans
Categories
TechnologyManagement & LeadershipHealthcareManufacturingScience & Research
Job Information
📋Core 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.
📋Job Type
full time
📊Experience Level
10+
💼Company Size
7419
📊Visa Sponsorship
No
💼Language
English
🏢Working Hours
40 hours
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