Quality Assurance Compliance Specialist

4 weeks ago


Bethlehem, Pennsylvania, United States Piramal Group Full time
Job Overview

The Principal Quality Assurance Compliance Specialist will play a crucial role in defining the roles and functions for the Electronic Systems team. This position will ensure that all computerized systems meet the required guidelines and regulations, including 21 CFR Part 11, EU Annex 11, and GAMP5.

Key Responsibilities
  • Ensure compliance with regulatory requirements and industry standards.
  • Perform and review computerized system validation life cycle deliverables.
  • Implement and maintain data integrity at the site as the Data Integrity Compliance Officer.
  • Coordinate with stakeholders to ensure effective data integrity and IT systems projects.
  • Participate in internal and external audits, and handle and participate in internal audits.
Requirements
  • Bachelor's degree in a relevant scientific or quality assurance field.
  • 5+ years of experience in quality assurance and compliance.
  • Strong understanding of pharmaceutical cGMP, industry standards, and regulations.
  • Excellent communication and interpersonal skills.
About Us

Piramal Group is a global healthcare company with a strong commitment to quality and compliance. We are proud to be an Equal Employment Opportunity and Affirmative Action employer, and we strive to create a diverse and inclusive work environment.



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