Senior analyst Quality Assurance

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

Quality and Regulatory Affairs Manager will be responsible for managing the local Quality Management System, as well as licensing and post marketing activities for assigned Perrigo brands.

Working with multiple functions and external stakeholders (including authorities) across different product categories (medicinal products, cosmetics, food supplements, medical devices, biocides) in the territory.

The role will be located at Perrigo Ukraine and will be reporting to Head of Regulatory, Quality, Safety Ukraine.

Scope of the Role

• Maintenance of local QMS (incl. verification and development of the current system)
• Conduct of self-inspections and audits
• Change management process, deviations, CAPAs, outsourcing activities, etc
• Provide trainings to relevant stakeholders
• Obtaining approval for import of products and batch release
• Participation in inspections
• Ability to manage pharmaceutical warehouse
• Oversight for some regulatory licencing and post marketing regulatory activities.
• Ensuring strategies and relationships with internal (e.g. GPS, CQA, Global Supply, CSCI Marketing, Commercial) and external stakeholders
• Ensuring company’s regulatory affairs activities are conducted according to relevant regulations, laws, and standards in the region.
  
  

Experience Required

• Minimum 4 years’ experience from the pharmaceutical/life science/selfcare industry, with a focus on quality and regulatory affairs applying to OTC/ self-care products . Understanding of pharmacovigilance will be an added value.
• A scientific degree in a pharmaceutical discipline.
• Experience in conducting of specialized examination of registration dossiers for medicinal products.
• Experience in preparation of documents for the procedure of confirming the compliance of the conditions of production of medicinal products with the requirements of GMP in accordance with the requirements of the order of the Ministry of Health
• Experience in handling of registration dossier.
• Experience in the processes of registration, re-registration and making changes to the registration dossiers for finished medicines, dietary supplements, medical products.
• Knowledge of the regulatory framework of the pharmaceutical industry, in [articular the requirements of GDP and ISO 13485 and ISO 22716
• Person speaking Fluent English (at least advanced level)
• Ability to manage cross-functional projects efficiently.
• Proactive and results-oriented: takes ownership, can work independently, has a can-do attitude
  
  

Hybrid working model (2 days work from home, 3 days work from the pharmaceutical warehouse)

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

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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. Our full Equal Employment Opportunity and Affirmative Action Policy Statement is available on our main career site in English and Spanish and will be provided in other accessible forms for persons with disabilities. #DIV #weareperrigo