IT Validation Specialist

1 month ago


Mumbai, Maharashtra, India Piramal Group Full time

Business: PPL Central Partner Functions Department: IT Location: Kurla, Mumbai Travel: Moderate

Job Overview To perform and document Computer System Validation as per defined processes at Corporate IT and across Piramal Pharma sites.

Key Stakeholders: Internal

Business – Site / Corporate functions

IT Team (SAP/ Infra / Quality IT / Allied / SAP Basis)

Key Stakeholders: External
•IT Vendors •IT Contractors/Consultants
Reporting Structure Reporting to Senior Manager – CSV
Experience
•Candidate with – years of experience in Pharma/Life science domain working on CSV, Part /Annex , especially for SAP projects.
•Work experience in both IT Sector and Pharma Sector will be desirable
Competencies
•Experience in Authoring all CSV deliverables URS, FRS, CS, IQ, OQ, PQ, RTM, VSR, Risk assessment, etc. as per "V" Model for IT projects
•Experience on validation of any of the enterprise level applications. SAP/HANA, Trackwise, Ensur/Documentum, LIMS, LMS, Chromatographic, Serialization, etc.
•Author, review and approval of SOPs, Guidelines/Policies as applicable.
•To have functional knowledge of Regulatory guidelines, Quality and Manufacturing processes.
•A team player with good communication skills (verbal & written)
•Any other tasks as assigned by his/her reporting manager

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