Quality Assurance Associate, Qp

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®, ACO®, 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 a blended-branded business to win in self-care. **Description Overview**: **Scope of the Role**: - Ensure adherence to critical procedures and compliance to requirements for record retention. - Set up and maintain Quality Agreements with third-parties (contract manufacturers, logistic service providers, distributors). - Help with due diligence and integration of new product developments / new product introductions for assigned categories. - Support technical transfers, qualification and validation work. - Investigate quality incidents, deviations and complaints, identify and follow-up CAPA’s and supplier improvement plans together with third-party contract manufacturers. - Evaluate and follow-up Change Controls together with the Regulatory Affairs team. - Review Product Quality Reviews. - Agree stability programs and review stability results. - Be part of third-party qualification and regular third-party auditing. - Assist in performing internal QA audits. - Support in the maintenance of the Quality Management System by creating and updating Standard Operating Procedures, Best Practices and Working Instructions. - Provide support in establishing and maintaining the Quality Management System - Provide input to risk management plan and risk management file in line with ICH Q9 and ISO 14971 - Provide input for analysis of data and/or management review - Provide QA training to the entire group regarding QA systems and processes and evaluate training effectiveness. - Maintain databases and documents according to good documentation practices and record retention procedure. - Assist in the GDP administrative batch control procedure. - Assist in EU QP release of medicinal products in line with the applicable regulations. - Identify gaps and areas for improvement in QA processes and handling and lead remedial actions and initiatives. - Keep a going awareness of new and developing regulations related to GDPs and GMPs. - You will follow up on actions of complaints if requested. - You will support in data and document collection for regulatory purposes. - You will ensure ongoing inspection readiness in your area of responsibilities. - Coordinate Change control process and follow-up implementation of changes. - Provide evidence to perform review of implementation and effectiveness with regard to corrective and preventive actions. **Experience Required**: - Master degree in pharmaceutical sciences, engineering, biochemistry, chemistry or equivalent through experience - Being approved as a Qualified Person (EU release of medicines) - At least 3-5 years relevant experience in Quality Assurance / Quality Control / Production - Good knowledge of the relevant European regulations for pharmaceutical products - Knowledge of FDA regulations for pharmaceutical products is advantageous - You are fluent in spoken and written English, other 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** - 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_