Piramal Group has interests in a portfolio of businesses including financial services (Piramal Enterprises Limited), pharmaceuticals (Piramal Pharma Limited), and real estate (Piramal Realty). With operations in 30 countries and brand presence in over 100 markets, the Group’s turnover is ~1.9 billion usd in FY 2022. Driven by its core values, the Group pursues inclusive growth, while adhering to ethical and value-driven practices.
Post : Deputy Manager - CSV IT
Department : Information Technology (CSV)
Location : Kurla, Mumbai
Qualification : Graduation – Science / Pharmacy / Engineering Post Graduation – Science / MBA preferred
Experience :
• 3 – 5 years of experience in pharma/life science domain - QC, QA, IT, CSV etc.
• Authoring CSV deliverables - URS, FRS, CS, IQ, OQ, PQ, RTM, VSR, risk assessment, etc. as per “V” Model for IT projects.
• Validation experience of any enterprise level applications - Trackwise, Ensur/Documentum, LIMS, LMS, SAP/HANA etc.
Skills Required :
• Knowledge of 21 CFR Part 11 / Annexure 11, CSV, GAMP 5, data integrity requirements for Pharma, Computer Software Assurance, IT systems and ITIL processes (e.g. backup/ restoration, infrastructure qualification, user access management etc.), Pharma 4.0.
• Awareness of industry best practices.
• Good to have functional knowledge of regulatory guidelines, quality control and manufacturing processes.
Key Responsibilities
• Ensure compliance of CSV documentation during various phases of software lifecycle.
• Create infrastructure (network, servers, cloud, database) qualification documentation, QMS documents - change control/deviation/incidents discrepancy/user access forms.
• Perform root cause analysis and define CAPA based on QMS documents review, and audit trail review of computerized systems as per defined frequency.
• Support initiatives of Quality eCompliance and CSV team across the corporate/PEL sites.
• Perform IT supplier assessment and ensure compliance of audit observations.
• Liaise with site ITC spocs for CSV activities and IT compliance initiatives.
• Guide and train IT & CSV teams (corporate & site) for CSV, data integrity and regulatory compliance activities.
• Ability to represent during regulatory audits and perform corporate & DI audits of sites.
• Coordinate with CSV & Project Manager to meet project timelines
Send your CV to Nikita.Dhuri@piramal.com
Last Date : 25th February 2025
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