Digital System Validator

6 days ago


Mumbai, Maharashtra, India beBeeSystemValidator Full time ₹ 1,50,00,000 - ₹ 2,50,00,000

We are seeking a seasoned professional to join our organization as a Senior Manager. As a key member of the team, you will be responsible for performing and documenting Computer System Validation of GxP Systems according to defined processes.

About this role:

  • Validate computer systems to ensure compliance with regulatory requirements
  • Create end-to-end validation deliverables for IT projects (e.g., URS, FRS, CS, IQ, OQ, PQ, RTM, VSR, Risk assessment)
  • Liaise with stakeholders to ensure project timelines are met

Key Responsibilities:

  • Perform root cause analysis and define CAPA based on QMS documents review
  • Guide and train teams for CSV, and CSV Regulatory Compliance activities
  • Collaborate with business, IT, quality and project managers to ensure project success

Requirements:

  • Graduate in Science/Pharmacy/Engineering
  • Post-Graduation - MPharm/Science/MBA (Desirable)
  • 10-14 years of experience in Pharma/Life science domain working on CSV, Part 11/Annex 11, Data Integrity

Preferred Qualifications:

  • Experience in working with various geographical locations and cross-functional sites
  • Experience of validation on automation/digitization projects


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