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Job Description
Manager - Quality eComplianceJob Description Business: PPL Department: Quality eComplainceLocation:
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
Job details are sourced from the employer's original posting.
Open job postingAbout the company
Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. They serve clients through a globally integrated network of facilities in North America, Europe, and Asia.