QA Engineer II

Quality Minneapolis, Minnesota


Descripción

Perrigo Company is dedicated to making lives better by bringing high quality and affordable self-care products that consumers trust everywhere they are sold.  Help us do it.

Provides primary Quality Assurance review and approval for documents such as Product Development, Process Validation, Equipment Qualification, Computer Software Validation, Method Validation, deviations, and other cGMP documentation and studies conducted at Perrigo Minnesota.

MAJOR RESPONSBILITIES:

  • Supports the performance of quality risk assessments.
  • Ensures that all information and documentation conform to company policy, cGMP’s and all other applicable FDA guidance’s.
  • Develops and evaluates quality, system and process standards to ensure reliability and compliance with company standards and governmental and regulatory requirements.

KNOWLEDGE, EXPERIENCE AND EDUCATION

 

  • Bachelor’s degree in a scientific discipline or closely aligned field.
  • Minimum of five years of experience working in an FDA regulated industry, pharmaceutical experience highly preferred
  • Demonstrated understanding of and ability to apply cGMPs and US FDA laws and requirements in an FDA regulated industry.
  • Strong functional knowledge of SAP systems.
  • Demonstrated ability to organize multiple tasks and change priorities to meet project deadlines