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Quality Assurance Associate

Location: 

Ghent, BE, 9050

 

At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill®, Compeed®, Solpadeine®, NiQuitin®, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.

 

Join us on our One Perrigo journey as we evolve to win in self-care.

 

Description Overview

For our Quality Team in Ghent, we are looking for a motivated Quality Assurance Associate. In this position, you will act in line with the Quality Assurance (QA) vision, strategy, and standards of the integrated Corporate & Country QA group, ensuring compliance and consistency across all processes.

Scope of the Role

Product lifecycle and technical support

  • Help with due diligence and integration of new product developments / new product introductions for assigned categories
  • Support technical transfers, qualification and validation work
  • Agree stability programs and review stability results
  • Write and review Product Quality Reviews
  • Evaluate and follow-up Change Controls together with the Regulatory Affairs team
  • You will support in data and document collection for regulatory purposes
  • Provide input to Quality risk management in line with ICH Q9
  • Providing support in projects

Audits, inspection & Compliance

  • Assist in performing internal QA audits.
  • Be part of third-party qualification and regular third-party auditing
  • Ensure ongoing inspection readiness in your area of responsibilities
  • Keep a going awareness of new and developing regulations related to GDPs and GMPs

Third-party management

  • Set up and maintain Quality Agreements with third-parties (contract manufacturers, logistic service providers, distributors)
  • Investigate quality incidents, deviations and complaints, identify and follow-up CAPA’s and supplier improvement plans together with third-party contract manufacturers and (Logistic) Service Providers
  • Coordinate, evaluate and follow-up on change controls in collaboration with the Regulatory Affairs team, ensuring correct and timely implementation of changes

Quality Management System

  • Provide support in establishing and maintaining the Quality Management System
  • Support in the maintenance of the Quality Management System by creating and updating Standard Operating Procedures, Best Practices and Working Instructions
  • Maintain databases and documents according to good documentation practices and record retention procedure
  • Ensure adherence to critical procedures and compliance to requirements for record retention
  • Provide input for analysis of data and/or management review
  • Provide evidence to perform review of implementation and effectiveness with regard to corrective and preventive actions
  • Identify gaps and areas for improvement in QA processes and handling and lead remedial actions and initiatives

Experience Required

  • Master’s degree in Pharmaceutical Sciences, Engineering, Biochemistry, Chemistry or equivalent through experience

  • Minimum 5 years of relevant experience in Quality Assurance, Quality Control, or Production

  • Solid knowledge of European regulations for pharmaceutical products

  • Knowledge of FDA regulations is considered an asset

  • Self-starter, capable of working autonomously at corporate level

  • Clear communicator, practical and solution-oriented

  • Enthusiastic personality with a “get the job done” mentality

  • Strong project management skills and proven ability to work in a multicultural team environment

  • Persistent drive for results in a fast-paced environment, with strong organizational and problem-solving skills

  • Fluency in spoken and written English; additional languages are an asset

Benefits
We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.

Find out more about Total Rewards at Perrigo. 

 

Hybrid Working Approach
We love our offices and the setting they provide for in-person collaboration and celebration. But we also appreciate the opportunity to work remotely can energise you too, so we promote flexibility with the ability to work two days a week from home in many roles.

 

We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more here

 

Applicants please note: To apply to this position please click the APPLY button at the bottom of the application.  (The SAVE button will only save your profile information but not submit an application for this open position.)  Thank you.

 

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law.  #weareperrigo

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