Job Description

Business: PPL

Department: Quality eComplaince

Location: Navi Mumbai
Travel: Low

We are looking for a responsible professional to manage Computer System Validation (CSV) and IT compliance activities at the site. The role involves defining validation strategies, reviewing validation and QMS documents, and ensuring computerized systems remain compliant throughout their lifecycle.

The incumbent will support Corporate Quality eCompliance initiatives, coordinate with vendors and project teams, participate in audits, and perform periodic reviews, data integrity checks, and gap assessments. The role also includes guiding site teams and supporting automation and compliance projects to meet regulatory and quality standards.

Roles & Responsibilities:

• To define validation strategy and review computer system validation deliverables for site IT projects e.g. URS, FRS, CS, IQ, OQ, PQ, RTM, VSR, Risk Assessment, etc. for installed applications at site.
• Author, Review and Approval of SOPs, Guidelines/Policies as applicable to computer system validations.
• To support the initiatives undertaken by Corporate Quality eCompliance team across Piramal Sites.
• To represent the site during regulatory or internal audits and to provide compliance against the audit findings for computer systems.
• To perform the periodic internal audits/assessments to check the IT/OT systems remain in compliant state.
• To perform the Data Integrity audit of site.
• Accountable to ensure compliance of computer system validation documentation during various phases (project, operational & retirement) of software lifecycle (SLC).
• To ensure IT infrastructure (Network, Servers, Cloud, Database) are qualified as per the required quality standards and required documents are in place.
• To review QMS documents e.g. Change control/Deviations/User access forms.
• To review and approve Root Cause Analysis and CAPA based on QMS documents.
• To perform Gap assessment as per applicable regulatory guidelines/ updates.
• To coordinate with Vendor (third party for validation) for timely completion of validation/qualification activities.
• To participate in automation and harmonization projects initiated by corporate / site team.
• To perform the periodic review of computerized systems.
• To attend QeC Governance call and provide timely response / updates to corporate QeC.
• To work along with CSV & Project Manager to ensure project timelines are met.
• To guide and mentor site teams on compliance of IT and electronic systems.

• Masters/bachelor’s degree in chemistry or a related field.

In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.
Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.
Equal employment opportunity
Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.

We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.