Quality Assurance Specialist

13 hours ago

Vapi, Gujarat, India beBeeQualityAssurance Full time ₹ 8,00,000 - ₹ 15,00,000
Quality Assurance Specialist

The Quality Assurance (QA) Specialist plays a vital role in implementing and ensuring compliance with industry best practices, specifically cGMP (Current Good Manufacturing Practice), across the entire project lifecycle.

Key Responsibilities:

  • Develop and maintain comprehensive engineering/project documentation, qualification & validation documents, adhering to regulatory requirements and industry standards.
  • Prepare and review qualification documents such as URS, DQ, IQ, OQ, and PQ for production and utility equipment, ensuring accuracy and completeness.
  • Oversee the creation of engineering documents, including certificates, calibration records, test results, inspection requests, non-compliance reports, and site instructions/observations, as well as permanent materials delivered and other critical QA/QC documents.
  • Conduct factory acceptance testing at vendor sites.
  • Qualify new equipment and schedule periodic re-qualifications for facilities, utilities, and PW plant HVAC.
  • Develop, review, and approve SOPs for the Engineering department.
  • Provide training and approval for qualification SOPs.
  • Prepare facility qualification documents and project-specific qualification plans for major changes.
  • Document, install, and operational qualify protocols and reports for performance qualification.
  • Train new joiners and executives on qualification activities.

Requirements:

  • Bachelor's degree in Chemical or Mechanical Engineering.
  • 2-4 years of experience in Engineering/Project documentation.
  • Excellent written and verbal communication skills.

This role is ideal for a detail-oriented professional with a strong background in quality assurance and project management, who can effectively collaborate with cross-functional teams to drive process improvements and ensure compliance with regulatory requirements.

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