Executive-IT

Piramal Pharma Ltd; Ahmedabad District; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Piramal Pharma Solutions is seeking an Executive-IT to ensure IT CSV & GMP compliance across servers, networks, storage, desktops, and laboratory systems. The role involves executing CSV activities for GxP systems and maintaining compliance with GMP, GDP, GAMP 5, 21 CFR Part 11, and Annex 11, including data integrity aspects.

You will administer access controls, audit trails, backups, and security measures while drafting SOPs and validation records.

Qualifications

• Experience in IT CSV & GMP compliance for GxP systems.
• Knowledge of 21 CFR Part 11, Annex 11 and Data Integrity requirements.
• Ability to draft and maintain validation documents and SOPs.

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.

Skills

IT CSV & GMP Compliance

Job description

Job Description:

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

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.