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Qa specialist commercial release

Bern
Bavarian Nordic Berna GmbH
Inserat online seit: Veröffentlicht vor 4 Std.
Beschreibung

Are you driven by quality, detail, and the opportunity to contribute to a mission that truly matters? Are you ready to make an extraordinary impact? At Bavarian Nordic, we are on a mission to protect lives worldwide by developing and producing vaccines that tackle health threats. Our Bern site is expanding rapidly, brimming with innovation and energy, and we are searching for a passionate Quality Assurance (QA) Specialist to join our team. This is your chance to be part of something bigger, work alongside devoted experts, and shape the future of global health in one of the most dynamic environments out there! Boost our teamYou will join a tightly knit Quality Assurance organization led by the site QA (Fv P/QP) and composed of three collaborative teams, each united by a shared mission to deliver excellence and safeguard patient health every day:QA Operations team, dedicated to the review of batch records and close partnership with production teamsCompliance QA team, overseeing change requests, managing deviations, and ensuring precise regulatory documentation, process validation, inspections, QMR, and PQRCQV (Commissioning, Qualification & Validation) team, responsible for validation activities, engineering oversight, and IT QA Our Bern QA department is a collective of skilled and seasoned professionals, renowned for their unwavering standards and supportive spirit-proud custodians of quality who thrive on collaboration and a culture of helpfulness. About the roleAs a member of our QA team, you will work side by side with our Qualified Person (Fv P), directly influencing the release and distribution of life-saving vaccines across Switzerland and worldwide. You will play an essential role in ensuring our products are distributed safely, legally, and in compliance with regulatory requirements. Your key responsibilities will include:Supporting Fv P duties to ensure compliance with Swissmedic and GDP/GMP regulationsServing as direct support to the Qualified Person (Fv P) for Imported products and Distribution in the Swiss marketCoordinating products entering the Swiss market, including managing withdrawals or recalls related to released productsCoordinate product release and batch disposition for both Swiss and international marketsEnsuring alignment with current pharmaceutical regulatory requirements and industry standards, as well as BN quality standards and proceduresProviding guidance on quality and compliance matters to departments at Bavarian Nordic and managing relevant QMS records as QAParticipating in or leading quality improvement projects in collaboration with other Bavarian Nordic departments and support function visibility across the organizationManaging and reviewing quality documentation, such as certificates and change controlsCollaborating with internal teams, including Supply Chain & Planning, QA Operations, Audit Group, and external authorities (e.g., Swissmedic, EMA, FDA)Contributing to audits, vendor qualification, risk management, and continuous improvement efforts Qualifications:MSc in Pharmacy or an equivalent academic degree in Chemistry, Biology, or Life SciencesAt least 3 years of experience in Quality Assurance within the pharmaceutical industry or in related rolesComprehensive knowledge of GMP, GDP, and international regulatory standards including Swissmedic, Swiss federal laws and regulations governing wholesalesDemonstrated leadership in audits, regulatory inspections, and preparation for Swiss Health Authorities site inspectionsFull professional proficiency in both German and English As a person, we expect you to have a strong quality mindset who is ready to step up and make a difference, not only by performing the daily tasks, but also by challenging the status quo and harmonizing practices across teams and geographies. You have a sharp eye for detail and combine strong analytical skills with proactive thinking. You are an effective communicator and a collaborative team player, yet also highly self-motivated, independent, and accountable. About Bavarian NordicImproving and saving lives through innovative vaccines is at the heart of what we do at Bavarian Nordic. We are a fully integrated vaccine company focused on the development, manufacturing, and commercialization of life-saving vaccines, and the largest pure-play vaccine company in the world. In Bavarian Nordic, we believe in the power of the team, and you will be part of a global team of more than +1700 dedicated employees with diverse backgrounds and viewpoints, who are bound together by our commitment to protect lives every day. We believe in creating an inclusive and flexible workplace with a strong focus on personal and professional development, because we need each other to take things further. We operate in a world in constant flux and always explore new opportunities. So, if you are open-minded and have the willpower to succeed, we might be a perfect fit for you. Why join Bavarian Nordic?Be part of something meaningful. You will contribute to life-saving vaccines deliveryWork closely with decision-makers and have exposure to leadership, authorities, and global operationsOpportunity to grow - Develop your skills and take on more responsibility, with potential to evolve into people management or senior QA rolesHuman-sized site with big impact - Enjoy a close-knit team atmosphere while contributing globallyEasy access - Our Bern site is well-connected via public transport Ready to take the next step in your QA career and help bringing critical vaccines to market?Please complete the application form using the "Apply" link. We are interviewing on an ongoing basis and look forward to receiving your CV as soon as possible. It is not mandatory to send a cover letter. Applications submitted via email will not be considered. Join us and become part of a diverse team dedicated to making a difference together. We kindly request that head-hunters or recruitment agencies refrain from contacting us regarding this position. Founded in 1994, we have +30 years of experience developing life-saving vaccines. We are a global leader in smallpox and mpox vaccines. Our commercial product portfolio contains market-leading vaccines against rabies, tick-borne encephalitis, cholera, typhoid, and Ebola. We are headquartered in Denmark and have manufacturing, research, and sales offices across Europe and North America. Our values - our Bavarian Nordic DNA, as we like to call it - are what guide our actions every day. We act as persistent pioneers, embrace change, value being boosted by the team, and believe in protecting lives every day. If that is also a part of your DNA, we invite you to join us in Bavarian Nordic! Bavarian Nordic is an Equal Opportunity Employer. All qualified applications will receive consideration for employment and will not be discriminated against based on race, color, sex, sexual orientation, gender identity, national origin, disability, or protected veteran status. jid337dc59je jit0938je jiy25je

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