Associate Analyst Quality Systems

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**: We are looking for a Analyst Quality Systems & Compliance Associate. We offer a Hybrid working schedule, a mix of onsite and remote working each week. **Scope of the Role**: The **Quality Assurance Associate** is in charge of Perrigo Medical Devices products for: - ** CMO Management**:responsible for all QA activities associated with the management of the CMOs under his/her responsibility. - ** Product Quality Management**: responsible for all QA activities related to the products under his/her responsibility associated with the development of new products, manufacturing line transfers, stability studies and validation activities. - ** Technical File redaction**: responsible for the preparation of the Manufacturing, Quality and stability sections of the technical files related to the products under his/her responsibility - ** Support the maintenance of the Quality Management System**: ensure that the SOP and templates used in daily activities are up to date and compliant with the relevant standards. Works according to PERRIGO QMS. - ** Coordinate operational activities**:collaborating with all the relevant stakeholders, the Quality Assurance Specialist ensures that Perrigo products are at any time compliant with the relevant regulation and standards. He/She provides QA expertise to all departments. **1. CMO Management** a. Prepare, maintain and control Quality agreements. b. Build and maintain relationships with the relevant stakeholders at the CMO site. c. Review, challenge and approve the protocols/reports provided by the CMO. d. Facilitate the communication between the CMO and other team members **2. Product Quality Management** a. Establish and implement the QA strategy for the development of new products b. Follow-up on validation, verification and stability studies c. Ensure that the assigned parts of the Technical File are aligned with the current regulations **3. Quality Management System** a. Responsible for updating relevant SOP b. Follows the QMS during the execution of daily activities c. Support the QA team in the preparation and execution of internal/external audits d. Responsible for discussing his/her work with the external auditors (NB/CA) e. Maintenance of database and documentation f. Ensure a close follow-up and a timely execution of all Quality processes related to his/her products. g. Contribute to the identification of GAP and point of improvement in the QMS **4. Coordinate Operational activities** a. Ensures that the released products are compliant with the current regulations b. Open and manage non-conformities, deviations, CAPA and other relevant QA processes c. Contribute to maintaining a correct product identification during the whole supply chain d. Support business needs **Experience Required**: - Scientific background with 2-3 years of experience in a pharmaceutical or medical devices company - Ideally, 1-2 years in quality assuranc - Good knowledge of ISO13485 and MDR - Good IT knowledge and skills - Self-starter, capable of working autonomously at corporate level - Clear communicator, practical and solution orientated - Enthusiastic and get the job done - Strong project management skills & team worker in a multicultural environment - Persistent drive for results in a fast-paced environment, utilizing sound project focus, organizational and problem solving skills - You speak and write fluently 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