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Executive-IT

Piramal Pharma

Ahmedabad, GJ, India1w ago

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Skills

21 cfr part 11application supportgmp

About the role

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Division

Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing  organization (CDMO), offering end-to-end development and manufacturing  solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.  

This enables us to offer a comprehensive range of services including Drug Discovery  Solutions, Process & Pharmaceutical Development services, Clinical Trial  Supplies, Commercial supply of APIs and Finished dosage forms. We also offer  specialized services like development and manufacture of Highly Potent APIs  and Antibody Drug Conjugation.  

Our capability as an integrated service provider  & experience with various technologies enables us to serve Innovator and  Generic companies worldwide.  

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Executive-IT

Job Description

IT CSV & GMP Compliance

Key Responsibilities:

Manage and maintain IT CSV & GMP Compliance including servers, networks, storage, desktops, and laboratory systems.
✅ Execute and maintain Computer System Validation (CSV) activities for GxP systems.
✅ Ensure compliance with GMP, GDP, GAMP 5, 21 CFR Part 11, Annex 11, and Data Integrity requirements.
✅ Administer user access, audit trails, backup, restoration, archival, and security controls.
✅ Draft and maintain SOPs, validation documents, and compliance records.
✅ Support laboratory applications, business systems, and end-user IT services.
✅ Coordinate with Corporate IT, vendors, and service providers for infrastructure and application support.
✅ Participate in IT projects, system upgrades, validation activities, and regulatory inspections.
✅ Ensure all IT activities are performed as per approved SOPs and quality guidelines.