Process Validation

17 hours ago

Chennai, Tamil Nadu, India HCLTech Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Role & responsibilities

Job Title Manufacturing Engineer/Process Validation Engineer

Location – Chennai

Delivery looking immediate joiner only

  • Conduct detailed gap assessments of current manufacturing practices against applicable medical regulatory standards (e.g., FDA, ISO 13485, EU MDR, GMP).
  • Review process controls, equipment validation, and quality systems documentation to identify non-compliances and areas for improvement.
  • Identify systemic issues and risk areas related to manufacturing quality, process robustness, and compliance.
  • Support remediation activities including process updates, validation efforts, documentation revisions, and training plans.
  • Strong understanding of regulatory standards including FDA 21 CFR Part 820, ISO 13485, GMP, and EU MDR.
  • Familiarity with process validation (IQ/OQ/PQ), and quality management systems.

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