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Job Description
Manager - ITJob Description BUSINESS: Piramal Pharma Limited DEPARTMENT: IT-CSV LOCATION: Kurla, Mumbai TRAVEL: Low Job Overview To perform Infrastructure qualification, Retirement/ decommissioning of infrastructure components and Computer System Validation as per defined processes at Corporate IT and across Piramal Pharma sites. Key Stakeholders: Internal
- Business Site / Corporate functions
- IT Team (e.g. SAP/ Infra / Quality IT / Allied / SAP Basis) Key Stakeholders: External
- IT Vendors
- IT Contractors/Consultants Reporting Structure Reporting to Associate General Manager IT CSV Experience
- Candidate with 10 15 years of experience in Pharma/Life science domain working on Infrastructure qualification activities, CSV, Part 11/Annex 11, Data Integrity
- Work experience in both IT Sector and Pharma Sector will be desirable Competencies
- To create infrastructure (Network, Servers, Cloud, Database) qualification documentation.
- Plan, execute, and document qualification activities for on-premise and cloud-based infrastructure, including IaaS, PaaS, and SaaS platforms.
- Author and execute server/application retirement documents
- Provide on-demand support for site infrastructure and Computer System Validation (CSV) activities as required.
- Plan and execute retirement or decommissioning of infrastructure components and cloud services (IaaS, PaaS, SaaS). Key Responsibilities
- Experience on validation of any of the enterprise level applications. e.g. Trackwise, Ensur/Documentum, LIMS, LMS, SAP/HANA, Chromatographic, Serialization, etc.
- Author, review and approval of SOPs, Guidelines/Policies as applicable.
- To create QMS documents e.g. Change control/Deviation/Incidents-Discrepancy/User access forms.
- To perform Root cause analysis and define CAPA based on QMS documents review.
- To support the initiatives undertaken by Quality eCompliance and CSV team across the Corporate/PEL sites.
- Experience in Authoring of all CSV deliverables e.g. URS, FRS, SDS, CS, IQ, OQ, PQ, RTM, VSR, Risk assessment, etc. as per V Model for IT projects
- To liaise with Site ITC 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.
- Knowledge of IT systems and ITIL processes (e.g. Backup/Restoration, Infrastructure qualification, User access Management, etc.)
- Ability to represent during regulatory audits and can able to perform Corporate & DI Audits of sites. To work along with CSV & Project Manager to ensure project timelines are metFull time
