Manager - Quality eCompliance

Piramal Pharma Limited; Navi Mumbai; In loco; INR 1.200.000 - 1.800.000; Tempo pieno

Descrizione del lavoro

Piramal Pharma Limited at Navi Mumbai seeks a responsible professional to manage Computer System Validation (CSV) and IT compliance activities at the site. The role defines validation strategies, reviews validation and QMS documents, and ensures computerized systems stay 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,

Mansioni

• Define validation strategy and review CSV deliverables for site IT projects (URS, FRS, CS, IQ, OQ, PQ, RTM, VSR, Risk Assessment).
• Author, review and approve SOPs and guidelines related to computer system validations.
• Support Corporate Quality eCompliance initiatives across Piramal Sites.
• Represent the site during regulatory or internal audits and address findings for computer systems.
• Perform periodic internal audits/assessments to ensure IT/OT systems remain compliant.
• Perform Data Integrity audits for the site.
• Ensure IT infrastructure is qualified and proper documents are in place.
• Review QMS documents such as Change control/Deviations/User access forms.
• Review and approve Root Cause Analysis and CAPA based on QMS documents.
• Perform gap assessments per regulatory guidelines/updates.
• Coordinate with vendors for timely completion of validation activities.

Descrizione del lavoro

Job Overview

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.

Location: Navi Mumbai

Travel: Low

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.

Full time

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.