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Senior quality assurance manager (m/f/d)

Bern
1100 Mylan Pharmaceuticals Inc.
Inserat online seit: 8 September
Beschreibung

Senior Quality Assurance Manager (m/f/d) page is loaded## Senior Quality Assurance Manager (m/f/d)locations: Zug-Officetime type: Tiempo completoposted on: Publicado ayerjob requisition id: R5659315Viatris Pharma GmbHEn VIATRIS, vemos la atención médica no como es, sino como debería de ser. Actuamos con valentía y estamos en una posición única para ser una fuente de estabilidad en un mundo de necesidades de atención médica en constante evolución.Viatris ayuda a las personas de todo el mundo a vivir de manera más saludable en cada etapa de la vida.Lo hacemos a través de:Acceso – suministrando medicamentos de confianza y de alta calidad independientemente de la geografía o las circunstancias;Liderazgo – promoviendo operaciones sostenibles y soluciones innovadoras para mejorar la salud del paciente;Colaboración – aprovechando nuestra experiencia común para conectar a las personas con productos y servicios.Our global portfolio includes best-in-class, iconic brand-name products as well as global key brands; generics, including branded and complex generics; and other offerings across a wide range of therapeutic areas. We are committed to helping create healthier communities worldwide through education, outreach and better access to treatment.For those driven to live their lives with purpose, Viatris helps employees realise their full potential by creating a collaborative culture that fosters courage and resilience. Viatris is more than just a place to work. This is a place to make a difference in the world.**The Role & What You Will Be Doing**As Senior Manager Quality Assurance and Deputy QP (FvP), you will play a key role in ensuring regulatory compliance and product quality across several Swiss legal entities. Your main responsibilities include:* Acting as Deputy QP (FvP), including batch disposition, recalls, and ensuring GDP-compliant distribution* Leading and maintaining the local Quality Management System (QMS) in line with GMP/GDP standards* Serving as primary quality contact for Swissmedic, cantonal authorities, and external partners* Conducting management reviews, self-inspections, and release of reworked batches/products* Acting as Person Responsible for Regulatory Compliance (PRRC) under the Swiss Medical Devices Ordinance* Managing responsibilities related to narcotics and controlled substances according to Swiss regulations* Handling deviations, complaints, CAPA activities, and product recalls* Approving and maintaining quality-relevant documentation (SOPs, PQRs, Technical Quality Agreements)* Supporting supplier qualification and overseeing training activities**About Your Skills & Experience**For this role, we’re looking for a candidate who has an effective combination of the following qualifications, skills and experiences:* University degree in pharmacy or a scientific discipline (e.g., chemistry, biology)* 8+ years of experience in the pharmaceutical industry, including minimum 5 years in Quality Assurance* Proven experience as Swiss QP (FvP) or Deputy QP (minimum 3 years)* In-depth knowledge of regulatory requirements (TPA, MPLO, GDP, GMP, BetmG)* Strong decision-making and communication skills, able to act independently and responsibly* Fluency in English and German (spoken and written); French is a plus* Experience in liaising with Swissmedic and international regulatory authorities is an advantageAt Viatris, we are dedicated to building a truly diverse, inclusive and authentic workplace, so if you’re excited about this role but your past experience doesn’t fully align with every requirement, we still encourage you to apply. You may just be the right candidate for this or other roles.At Viatris, we offer competitive salaries, benefits and an inclusive environment where you can use your experiences, perspectives and skills to help make an impact on the lives of others. You will also have the opportunity to access excellent career progression opportunities and work-life balance initiatives.**Diversity & Inclusion at Viatris**At Viatris, diversity and inclusion are essential to our mission. The diversity we foster in all aspects of our business can be one of our greatest strengths in redefining healthcare not as it is, but as it should be. If you would like to know more about what diversity, equity and inclusion means to us, please visit**Sustainability at Viatris**Corporate social responsibility is fundamental to the Viatris mission. We work to advance responsible and sustainable operations and leverage our collective expertise to empower people to live healthier at every stage of life, recognizing that our actions affect the stakeholders and communities we serve. To learn more about our efforts, please visitEn Viatris, ofrecemos salarios competitivos, beneficios y un entorno inclusivo donde puede usar sus experiencias, perspectivas y habilidades para ayudar a generar un impacto en la vida de los demás.Viatris es una compañía global del cuidado de la salud creada en 2020 a través de la combinación de Mylan y Upjohn, una división legada de Pfizer. Al integrar las fortalezas de estas dos compañías, incluida nuestra fuerza laboral global de aprox. 45,000, nuestro objetivo es proporcionar acceso mejorado a medicamentos de calidad asequibles a pacientes de todo el mundo, independientemente de dónde vivan o de las circunstancias. Creemos en el cuidado de la salud como debe ser: empoderamos a las personas de todo el mundo para que vivan de manera más saludable en cada etapa de la vida. Debido a nuestra creencia firme de que un acceso mejorado permite una mejor salud, aprovechamos nuestra experiencia científica y de manufactura inmejorable, al igual que las capacidades comerciales comprobadas, para ofrecer a los pacientes medicamentos de calidad en el momento y en el lugar que los necesiten.
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