Job Description

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.

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.

Hands-on experience on testing tools like HP ALM, Kneat and SNOW

LS Domain->Computer System Validation (CSV)