Manager - Quality eCompliance

Piramal Pharma Ltd; Mumbai; On-site; INR 1,800,000 - 2,800,000; Full time

Job summary

Piramal Pharma Ltd is seeking a Manager - Quality eCompliance to lead CSV and IT compliance activities at the Navi Mumbai site. You will define validation strategies, review validation and QMS documents, and ensure computerized systems remain compliant throughout their lifecycle.

The role includes coordinating with Corporate Quality eCompliance, participating in audits, data integrity checks, gap assessments, and guiding site teams on IT/electronic systems compliance and automation initiatives.

Qualifications

• Define validation strategy and review CSV deliverables for site IT projects.
• Author, review and approve SOPs for computer system validations.
• Represent site in regulatory/internal audits and address findings.
• Perform internal IT/OT audits and data integrity reviews.
• Coordinate with third-party validation vendors to meet timelines.
• Guide site teams on IT and electronic systems compliance.

Responsibilities

• Define validation strategy and review CS/URS/FS documents for site IT projects.
• Review and approve SOPs and guidelines related to computer system validations.
• Support Corporate Quality eCompliance initiatives across Piramal sites.
• Represent the site during audits and provide evidence against findings.
• Conduct periodic IT/OT audits and data integrity checks.
• Collaborate with vendors for timely validation activities.
• Mentor site teams on compliance of IT and electronic systems.

Skills

CSV management

IT compliance

Validation strategy

QMS documentation

Audits

Data integrity

CAPA & RCA

Vendor coordination

Job description

Job Description

Manager - Quality eComplianceJob Description Business: PPL Department: Quality eComplaince Location: Navi Mumbai Travel: Low 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.

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