QA External Operations Professional

Quality Allegan, Michigan


Description

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.

The QA External Operations professional is responsible for the oversight and management of supplier Quality Management System for contract manufacturers.  Works to identify and mediate the risk to the company and monitor the compliance and execution of external contract manufacturing quality systems.

Other primary duties and responsibilities will include:

  • Qualification and approval of contract manufacturers per procedures.
  • Communicates and approves contract manufacturer change control activities with input from appropriate Subject matter Experts per procedures.
  • Acts as primary contact/facilitator for external contract manufacturers on all quality related issues.
  • Creation and maintenance of quality agreements with Contract manufacturer per procedures
  • Deviation investigation oversight,  CAPA assignment and tracking, batch disposition and batch release support. 
  • Performs audits of contract manufacturer per procedures.
  • Quality oversight of new product development with contract manufacturers.  Key participant in project teams.
Requirements & Qualifications: 

  • Bachelor’s degree in a scientific discipline or closely aligned field, with Master’s degree preferred. 
  • Six to eight (6-8) years professional experience in Quality or Operations, with in-depth knowledge and experience in pharmaceutical categories such as Drug, API, Medical Device, and/ or Dietary Supplements. 
  • Strong grasp of cGMP standards and requirements in an FDA regulated industry and the ability to interpret and apply these regulations and their application.
  • Excellent oral and written communication skills at all levels of the organization and good interpersonal and relational skill.

#DIV

We are seeking a diverse applicant pool to ensure the diversity of our team reflects the end consumers we serve through our self-care mission. We are proud to be an equal opportunity employer that celebrates our team’s differences. Individuals of all races, ethnicities, nationalities, ancestries, religious creeds, sexual orientations, genders, gender identities and gender expressions, national origins, ages, mental and physical abilities, familial status,’ veterans status’, military status’ and more are encouraged to apply. TOGETHER, we make lives better.