IT Quality Specialist

4 days ago

Pune, Maharashtra, India beBeeItquality Full time ₹ 90,00,000 - ₹ 1,50,00,000

Job Overview

We are seeking a highly skilled IT Quality Professional to lead our effort in managing and maintaining the validation of computerized systems in the Life Sciences industry. The ideal candidate will have 6+ years of professional experience and strong knowledge in real-time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation.

  • Create validation plans, reports, and review validation documents such as URS, FS, FRA, DD, IQ, OQ, PQ's, TRM.
  • Ensure compliance with GxP (GMP, GCP, GLP) & privacy requirements.
  • Develop and maintain IT GxP compliance documentation.
  • Ensure GxP Computerized Systems are validated as per GAMP -5 requirements.

Tech Requirements

  • Hands-on experience on testing tools like HP ALM, Kneat and SNOW.
  • Experience in MES, QMS (Trackwise), Lab solutions i.e. LIMS, Empower CDS, Chromeleon, Business Analytics, Middle wares etc.
  • OT System Qualification (Radio ligand Therapy or critical dosage forms).
  • PAS/DCS Qualification.
  • High level of understanding in OT Security, ISA95.

About the Role

This is an excellent opportunity for a motivated and experienced IT Quality Professional to join our team. If you are looking for a challenging role that offers opportunities for growth and development, please apply.

Key Responsibilities

The successful candidate will be responsible for leading our effort in managing and maintaining the validation of computerized systems in the Life Sciences industry. This will involve creating validation plans, reports, and reviewing validation documents, ensuring compliance with GxP (GMP, GCP, GLP) & privacy requirements, developing and maintaining IT GxP compliance documentation, and ensuring GxP Computerized Systems are validated as per GAMP -5 requirements.

Requirements

  • 6+ years of professional experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation.
  • Strong knowledge in real-time experience in IT Quality & Compliance, Computer System Validation / Software Testing / System Implementation.
  • Hands-on experience on testing tools like HP ALM, Kneat and SNOW.
  • Experience in MES, QMS (Trackwise), Lab solutions i.e. LIMS, Empower CDS, Chromeleon, Business Analytics, Middle wares etc.
  • OT System Qualification (Radio ligand Therapy or critical dosage forms).
  • PAS/DCS Qualification.
  • High level of understanding in OT Security, ISA95.

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