Senior Validation Specialist

5 days ago

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

Job Overview

This position entails performing and documenting Computer System Validation of GxP Systems in accordance with defined processes at Central Partner Functions and across multiple sites.

Key Responsibilities

  • To create end-to-end CSV deliverables for IT projects, including URS, FRS, CS, IQ, OQ, PQ, RTM, VSR, Risk assessment, etc.
  • To develop QMS documents, such as Change control/Deviation/Incidents-Discrepancy/User access forms.
  • To perform Root cause analysis and define CAPA based on QMS documents review.
  • To support Quality Automation Initiatives across the organization.

Required Skills and Qualifications

Competencies:

  • Good knowledge of 21 CFR Part 11 / Annexure 11.
  • Good knowledge of CSV, CSA, GAMP 5 Guidelines.
  • Good knowledge of Data Integrity requirements for Pharma.
  • Experience in working with various geographical Location Stakeholders.
  • Functional knowledge of CSV Regulatory guidelines, Quality Control and Manufacturing processes.

Working Conditions

This role requires strong communication skills, both verbal and written. Experience in working with global cross-functional teams is essential. Knowledge of industry best practices and awareness of Pharma 4.0 are also desirable.

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