To ensure regulatory compliance of IT and electronic systems for Piramal critical care sites and corporate. Responsible to support in implementation of IT Automation for quality processes across the Piramal Critical care sites.
Key Stakeholders: InternalSite functions - Site / Central Partner functions (e.g. SAP / Infra / Quality IT / Allied / SAP etc.)
Key Stakeholders: ExternalIT Vendors
IT Contractors/Consultant
To support the IT initiatives undertaken by IT/Quality eCompliance team across the Central/PPL sites.
To support Central and Site IT teams in CSV and other IT compliance activities with respect to regulatory guidelines.
To establish governance for PPL sites (India, UK and US) and conduct periodic meeting to review and improve the CSV and other IT compliance activities.
To perform Central & DI Audits of sites and to provide support during regulatory audits.
To define validation strategy and review CSV deliverables for IT projects.
To ensure compliance of CSV documentation.
To monitor third party resource engaged for site activities under shared services.
To review QMS documents e.g. Change control/Deviation/Incidents-Discrepancy.
To perform Root cause analysis and define CAPA based on QMS documents review.
To perform periodic and audit trail review of computerized systems as per defined frequency.
Perform IT Supplier assessment and ensure compliance of audit observations.
To liaise with Site QeC SPOC's for CSV activities and IT Compliance initiatives.
To guide and train IT & CSV teams (Corporate & Site) for CSV, Data Integrity and Regulatory Compliance activities.
To work along with CSV & Project Manager to ensure project timelines are met.
Author, review and approval of SOPs, Guidelines/Policies as applicable.
To inform DI Champion/PPL Manager in case of data integrity breach/issue.
Any other tasks as assigned by his/her reporting manager.
Good knowledge of IT compliance, 21 CFR Part 11 / Annexure 11 (Must)
Good knowledge of CSV, CSA, GAMP 5 Guidelines (Must)
Good knowledge of Data Integrity requirements for Pharma (Must)
Experience in working with various geographical Location Stakeholders such as US, European, APAC. (Must)
Good Verbal and Written communication skills (Must)
Functional knowledge of CSV Regulatory guidelines, Quality Control and Manufacturing processes (Must)
Knowledge of IT systems and ITIL processes (e.g. Backup/Restoration, Infrastructure qualification, User access Management, etc.) (Must)
Experience of working with Global Pharma Cross functional Sites - QC, QA, Manufacturing, IT, SAP etc. (Plus)
Experience of validation on automation/digitization projects (Plus)
Aware of industry best practices and knowledge about Pharma 4.0 (Plus)
Senior Manager - Quality eCompliance • Mumbai, India
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