Quality Assurance Specialist

7 days ago

Bengaluru, Karnataka, India beBee Careers Full time

Job Summary

The Senior Quality Assurance Specialist provides direct support to proprietary software by guiding the direction of the Quality Management System. This individual works with project and department leaders to ensure adherence to applicable regulations, industry standards, and project requirements. They mentor less experienced team members.

Clinical Role

This role supports the QA Department by conducting internal and vendor audits, assisting with client audits and regulatory inspections, and ensuring Quality Management System compliance management including CAPA, quality incidents, changes to the Standards/ QMS.

Key Responsibilities

  • Conducts internal audits of projects, processes, clinical sites, monitors, deliverables, and departments of moderate to complex scope.
  • Reviews documentation for accuracy and compliance.
  • Reviews and tracks non-compliances, deviations, and CAPAs.
  • Leads supplier/vendor qualification and evaluation.
  • Leads client audits and regulatory inspections.
  • Leads or participates in process improvement projects.
  • Assists in or creates audit schedules for one or more portions of the Quality Management System (QMS).
  • Writes and reviews corporate SOPs and policies.
  • Conducts trainings as needed.
  • Provides guidance or mentors and trains less experienced team members.
  • Represents the Quality Assurance department at meetings or events.
  • May contribute to solutions for corporate and global QA initiatives and tasks.

System Validation Role

This role involves auditing, developing, and implementing verification and validation (V&V) processes for both in-house and COTS software, and documenting these activities. The Quality Assurance Specialist will also assist in internal audits of IT and information security processes to ensure compliance with GCP, NIST SP 800-53, FISMA, 21 CFR Part 11 / EU Annex 11, GAMP 5, internal SOPs, and industry standards.

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