Executive-IT

Piramal Pharma Limited; Ahmedabad District; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Piramal Pharma Limited's Piramal Pharma Solutions division is seeking an Executive-IT to lead Computer System Validation (CSV) activities and ensure GMP, GDP, GAMP 5, 21 CFR Part 11, and Annex 11 compliance across GxP systems.

You will administer user access, audit trails, backups, and security controls, draft validation documents and SOPs, support lab applications and business systems, and coordinate with Corporate IT, vendors, and inspections to keep the IT landscape aligned with regulatory

Qualifications

Responsibilities

• Execute 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.

Job description

Be the First to Apply 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

• 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.

Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the- counter products. In addition, one of PPL’s associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group.

PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.