Quality Assurance Specialist

1 week ago

Vizag, Andhra Pradesh, India beBeeRegulator Full time ₹ 20,00,000 - ₹ 30,00,000

Job Summary:

We are seeking a seasoned professional to lead validation and configuration efforts for the life sciences domain.

This role involves hands-on experience in pharmaceutical quality systems and collaboration with global cross-functional teams.

Key Responsibilities:
  • Develop and execute test strategies, protocols, and test scripts to ensure high-quality, compliant systems.
  • Collaborate with cross-functional teams across QA, CSV, and business units to ensure accurate system validation.
  • Review SOPs, system documentation, and create traceability matrices to maintain regulatory compliance.
Requirements:
  • 5+ years of experience in QA/QC systems in the life sciences/pharmaceutical domain.
  • Proficiency in Trackwise, Labware LIMS, and Documentum D2 platforms.
  • Solid understanding of GAMP 5, FDA 21 CFR Part 11, and CSV best practices.

This position requires excellent communication and documentation skills, as well as a strong background in validation, configuration, and compliance-driven testing in a regulated environment.

The ideal candidate will be able to work effectively in a team environment and possess excellent problem-solving skills.

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