Business Piramal Critical Care Department Information Technology Location Kurla Travel Low Job OverviewTo 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 Consultants Reporting StructureReporting to Associate General Manager Relevant Experience QualificationGraduate Post-Graduate in Science Pharmacy Candidate with 10-14 years of experience in Pharma Life science domain Working on IT Compliance CSV Part 11 Annex 11 Data Integrity Experience in Pharma or IT Sector will be desirable Roles Responsibilities 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 CompetenciesMust have knowledge of IT compliance 21 CFR Part 11 Annexure 11 Must have knowledge of CSV CSA GAMP 5 Guidelines Must have knowledge of Data Integrity requirements for Pharma Must have experience in working with various geographical Location Stakeholders such as US European APAC Good Verbal and Written communication skills Functional knowledge of CSV Regulatory guidelines Quality Control and Manufacturing processes Knowledge of IT systems and ITIL processes e g Backup Restoration Infrastructure qualification User access Management etc Experience of working with Global Pharma Cross functional Sites - QC QA Manufacturing IT SAP etc Experience of validation on automation digitization projects Aware of industry best practices and knowledge about Pharma 4 0 In the three decades of its existence Piramal Group has pursued a twin strategy of both organic and inorganic growth Driven by its core values Piramal Group steadfastly pursues inclusive growth while adhering to ethical and values-driven practices Equal employment opportunityPiramal Group is proud to be an Equal Employment Chance and Affirmative Action employer We do not discriminate based upon race ethnicity religion color national origin gender including pregnancy childbirth or related medical conditions sexual orientation gender identity gender expression age status as a protected veteran status as an individual with a disability genetics or other applicable legally protected characteristics We base our employment decisions on merit considering qualifications skills performance and achievements We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters including recruitment selection training placement promotion demotion compensation and benefits transfers terminations and working conditions including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice Piramal Critical Care PCC under Piramal Pharma Limited PPL a subsidiary of Piramal Enterprises Limited is the third largest producer of Inhaled Anaesthetics and a global player in hospital generics Motivated by its vision to deliver critical care solutions for patients and healthcare providers across the globe PCC is committed to enabling sustainable and profitable growth for all its stakeholders PCC maintains a wide presence across the USA Europe and more than 100 countries across the globe Its rich product portfolio includes Inhalation Anaesthetics such as Sevoflurane Isoflurane and Halothane as well as Intrathecal Baclofen therapy for spasticity management PCC has wholly-owned state-of-the-art manufacturing facilities in the US and India that have successfully cleared periodical inspections by the US FDA UK MHRA and other regulators Its core strength lies in a highly qualified global workforce of more than 400 employees across 16 countries PCC is focused on further expanding its global footprint through new product additions in the critical care space Committed to corporate social responsibility alongside Piramal Group PCC collaborates with various partner organizations and proudly takes an active role in providing hope and resources to those in need as well as caring for the environment