Senior QP Specialist

Sever Pharma Solutions is a contract developer and manufacturer specializing in highly potent pharmaceuticals. Our headquarters in Malmö has developed and manufactured pharmaceuticals for nearly 50 years according to the rigorous standards required of pharmaceutical companies. Our customers range from large global to smaller pharmaceutical companies, and we have over 320 employees in Malmö and the USA. Would you like to be a key person in a growing, international organization where continuous improvement and patient safety are core values? We are now seeking an experienced and engaged Senior QP Specialist who can be part of Sever Pharma Solutions' continued growth and is ready to contribute your knowledge to ongoing development and a strengthened quality culture in an organization undergoing change. The Quality Department you will be joining consists of approximately 50 people, and you will report directly to the VP Director Quality. You will also work closely with another experienced QP. About the Role As a QP, you will have a central and independent role responsible for ensuring that manufactured pharmaceutical products meet applicable GMP requirements, regulatory requirements, and internal quality standards before certification and release. The role involves close collaboration with QA, QC, production, and other cross-functional groups in the organization. Your Areas of Responsibility • Certify and release manufactured pharmaceutical batches in accordance with applicable GMP and regulatory requirements • Ensure that raw materials, packaging materials, and finished products have been tested and approved according to established specifications • Review and approve deviations, changes, CAPA, and quality-related investigations • Ensure compliance with European and international regulatory requirements, including requirements from the Swedish Medical Products Agency, EMA, and FDA • Contribute to the development and improvement of quality processes and quality culture Your Background and Experience • You have an academic degree in pharmacy, chemistry, biomedicine, or similar at Master level • You have several years of experience as a Quality Assurance specialist, preferably also in other quality-related tasks in a GMP-governed operation • You are certified as a QP by the Swedish Medical Products Agency and have several years of experience in the international pharmaceutical industry, meeting the Swedish Medical Products Agency standard HSLF-FS 2021:102 • You have an agile working style and can prioritize your tasks; you are a good and clear communicator • Previous experience with sterile manufacturing in the pharmaceutical industry is a plus • You speak and write Swedish and English fluently As a person, you are confident, accustomed to working independently, and have the ability to make informed decisions based on your knowledge and experience. You drive your projects efficiently with continuous improvement as the goal. You have excellent collaboration skills and integrity in your role. You thrive in a developmental environment where change and improvement work are part of everyday life. You are meticulous, structured, and have a pronounced quality awareness that permeates your actions. You will be an important part of a very pleasant team in a stimulating environment where you get to participate in new development projects that often become reality in the form of state-of-the-art pharmaceuticals. We look forward to telling you more about the position and Sever Pharma Solutions! Don't hesitate to get in touch for more information or to have your questions answered. We will review applications on an ongoing basis. Warm welcome!

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