Senior Technical Trainer

5 days ago

Nagpur, Maharashtra, India beBeeValidation Full time ₹ 20,00,000 - ₹ 25,00,000

We are seeking a highly experienced Commissioning, Qualification, and Validation (CQV) trainer with over 10 years of proven expertise in the pharmaceutical and medical device sectors.

The ideal candidate will support global CQV projects remotely, ensuring compliance with FDA, EU, and other international regulations, including GxP standards.

This role involves the preparation, execution, and lifecycle management of CQV documentation for new and existing facilities, utilities, systems, and equipment.

Key Responsibilities:
  • Lead and execute CQV activities for manufacturing equipment, utilities (e.g., HVAC, WFI, clean steam), and computerized systems in compliance with regulatory and industry standards.
  • Develop and review CQV documentation including URS, DQ, FAT, SAT, IQ, OQ, PQ, and risk assessments (e.g., FMEA).
  • Manage and implement validation master plans (VMP) and system impact assessments.
  • Collaborate with cross-functional teams (engineering, QA, manufacturing, IT) to ensure seamless CQV integration into capital and remediation projects.
  • Conduct remote FAT/SAT support, data review, and validation strategy planning.
  • Support Data Integrity assessments and 21 CFR Part 11 compliance for computerized systems.
  • Ensure documentation complies with GAMP 5, FDA, EMA, and ISO 13485 (for medical devices) requirements.
  • Oversee remote execution of validation test protocols, ensuring deviations are captured and resolved.
  • Drive continuous improvement and risk-based validation strategies in line with current industry best practices.

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