Validation Expert Consultant

Responsibilities:

Well versed with Manufacturing, Quality and engineering system and their validations.
OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus), Client/DCS Integrated with Manufacturing Equipment qualification.
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.
OT System Qualification (Radio ligand Therapy or critical dosage forms will be a plus), Client/DCS Integrated with Manufacturing Equipment qualification.

Requirements:

10 to 12 years 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 (Track wise), Lab solutions i.e., LIMS, Empower CDS, Chrome Leon, Business Analytics, Middle wares etc.
Hands-on experience on testing tools like Client ALM, Kneat and SNOW
IT QMS.
Validation/Qualification.
Risk management.
Handling of defects/Deviations.
Investigations.
CAPA Handling.
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).
Client/DCS Qualification.
ISA95 High level of understanding.
OT Security will be a plus.
Standalone Systems Qualifications.
Client/DCS Integrated with Manufacturing Equipment qualification.