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.
Preferred Attributes:
- Certifications in CSV, GAMP, or related domains.
- Experience with cloud/SaaS validation.
- Experience in global cross-functional environments.
Required Skills & Qualifications:
- 12–15 years of pharmaceutical industry experience in GxP environments.
- Strong CSV experience with ERP, LIMS, QMS, LMS, DMS systems.
- Deep knowledge of GAMP 5, 21 CFR Part 11, Annex 11, data integrity principles.
- Strong documentation, communication, and stakeholder-management skills.
- Experience representing IT in regulatory audits.
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.
Amneal (NASDAQ: AMRX) is rapidly becoming one of the most dynamic, purpose-driven pharmaceutical companies delivering more affordable access to essential medicines. Our family delivers for yours through a robust U.S. generics business, a growing branded business and deepening portfolios in injectables, biosimilars and select international markets. We’ve bolstered our world-class scientific rigor, production capabilities and commercial infrastructure. And we invest substantially in our people through leadership development and employee well-being programs – all so we can deliver even more value. We are Amneal and We make healthy possible.
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