Validation Expert

6 hours ago


Bengaluru, Karnataka, India beBeeCompliance Full time ₹ 18,00,000 - ₹ 20,00,000
Quality Validation Engineer

As a Quality and Compliance Validation (CQV) expert, you will be responsible for ensuring the quality and compliance of our products and processes.

Key Responsibilities:

  • Commissioning Activities:
    • Author commissioning protocols for equipment and utilities, including Installation Checks and Functional Testing.
    • Participate in and coordinate with engineering & OEMs for Factory Acceptance Tests (FAT)/Site Acceptance Tests (SAT).
    • Author DQ, System Impact Assessment, and Risk Assessment documents in coordination with OEMs.
  • Qualification and Validation:
    • Author, review, and execute qualification protocols for process equipment, including Installation Qualification, Operational Qualification, and Performance Qualification.
    • Perform qualification as per regulatory requirements (e.g., FDA, WHO).
  • Documentation:
    • Maintain sound knowledge of good documentation practices and QMS processes throughout the CQV lifecycle.
    • Coordinate with engineering, manufacturing, QA/QC, and IT teams to ensure seamless project execution.
    • Provide technical input during project planning and scheduling of CQV activities.
    • Track and report progress of CQV milestones.

Required Skills and Qualifications:

  • 3-4 years of experience in pharma CQV
  • Strong knowledge of GMP regulations and guidelines
  • Excellent communication and writing skills
  • Project management skills

Benefits:

This role offers an exciting opportunity to work in a dynamic environment, contributing to the development of high-quality products.

About Us:

We are a leading company in the pharmaceutical industry, dedicated to delivering innovative solutions that meet the highest standards of quality and compliance.



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