Quality Assurance Manager for IT Systems

4 days ago


Saddle Brook, New Jersey, United States Lynkx Staffing LLC Full time
Job Description

Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical, and Medical Devices IT & Human Resources disciplines in New Jersey. We are seeking a Quality Assurance Manager for IT Systems to support our computerized system project teams in review and QA approval of system validation and infrastructure qualification documentation and protocols.

Key Responsibilities:
  • Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements.
  • Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements.
  • Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems.
Requirements:
  • Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance.
  • Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models.
  • Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4.

Salary Range: $110,000 - $130,000 per year.



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