Sever Pharma Solutions is a contract developer and manufacturer specializing in potent pharmaceuticals. Our headquarters in Malmö has developed and manufactured pharmaceuticals for nearly 50 years according to the high standards required in the pharmaceutical industry. Our customers range from large global to smaller pharmaceutical companies, and we have over 320 employees in Malmö and the USA.
Do you want to be an important key person in a growing, international organization where continuous improvement and patient safety are guiding principles? We are now looking for an experienced and committed 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 in transition.
The Quality Department that you will join consists of about 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 have a central and independent role with responsibility 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 Responsibilities
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, CAPAs, and quality-related investigations
Ensure compliance with European and international regulatory requirements, including requirements from the 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's level
You have several years of experience as a Quality Assurance specialist, and preferably also in other quality-related tasks in a GMP-regulated operation
You are certified as a QP by the Medical Products Agency and have several years of experience in the international pharmaceutical industry and meet the Medical Products Agency's standard HSLF-FS 2021:102
You have an agile working approach and can prioritize your tasks, and you are a good and clear communicator
Previous experience with sterile manufacturing in the pharmaceutical industry is a merit
You speak and write Swedish and English fluently
As a person, you are confident, accustomed to working independently, and have the ability to make decisions based on your knowledge and experience. You drive your projects efficiently with continuous improvement as your goal. You have excellent collaboration skills and integrity in your role. You thrive in a developing environment where change and improvement work are part of daily operations. You are thorough, 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 a 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 reach out for more information or to get answers to your questions. We will review applications continuously. We warmly welcome your application!Sever Pharma Solutions is a contract developer and manufacturer specializing in potent pharmaceuticals. Our headquarters in Malmö has developed and manufactured pharmaceuticals for nearly 50 years according to the high standards required in the pharmaceutical industry. Our customers range from large global to smaller pharmaceutical companies, and we have over 320 employees in Malmö and the USA.
Do you want to be an important key person in a growing, international organization where continuous improvement and patient safety are guiding principles? We are now looking for an experienced and…