CSV Consultant

Responsibilities Candidate will provide an application validation expertise practically on different scenarios as applicable case to case i.e., standalone/enterprise etc. Candidate will be accountable for authoring Validation Plan, and Validation Summary Reports and have fair understanding on other SDLC documents. Candidate must have fair conceptual understanding on below key areas o IT QMS o Validation/Qualification o Risk management. o Handling of defects/Deviations o Investigations o CAPA Handling o Test Management Compliance Candidate must have understating on latest regulations i.e. 21CFR Part 11, EU annex 11, and Guidelines e.g. GAMP5 guide. OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus) PAS/DCS Qualification ISA95 High level of understanding OT Security will be a plus. Standalone Systems Qualifications PAS/DCS Integrated with Manufacturing Equipment qualification.Technical and Professional Requirements:3+ yrs. of Professional experience and strong knowledge with real time experience in IT Quality Compliance, Computer System Validation / Software Testing / System Implementation in the Life Sciences industry. Well versed with Manufacturing, Quality and engineering system and their validations Stakeholder management and good executor with required communication. Knowledge of Pharmaceutical / Life Sciences as domain. Experience to MES, QMS (Trackwise), Lab solutions i.e. LIMS, Empower CDS, Chromeleon, Business Analytics, Middle wares etc. will be an advantage - OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus) - PAS/DCS Qualification - ISA95 High level of understanding - OT Security will be a plus. - Standalone Systems Qualifications - PAS/DCS Integrated with Manufacturing Equipment qualification.Preferred Skills:LS Domain-Computer System Validation (CSV)Additional Responsibilities:Hands-on experience on testing tools like HP ALM, Kneat and SNOWEducational RequirementsMaster Of Technology,Bachelor Of Science,Bachelor Of Technology,Bachelor of Engineering,Bachelor of Pharmacy (Honors),Master of PharmacyService LineApplication Development and Maintenance*Location of posting is subject to business requirements

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