Infosys

CSV Consultant

Posted On

Sept. 30, 2024

Location

Bangalore, Karnataka

Experience Level

5 - 12 Years Exp.

Job Type

Permanent

Apply By

Dec. 31, 2024

Job Description

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. Educational Requirements Master Of Technology,Bachelor Of Science,Bachelor Of Technology,Bachelor of Engineering,Bachelor of Pharmacy (Honors),Master of Pharmacy Additional Responsibities: Hands-on experience on testing tools like HP ALM, Kneat and SNOW 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.

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