Vacant job

Sever Pharma Solutions is a contract developer and manufacturer specialized in high-potency medicines. The headquarters in Malmö has been developing and manufacturing medicines for nearly 50 years, adhering to the high demands placed on pharmaceutical companies. Our customers range from large global entities to smaller pharmaceutical firms, and we have over 320 employees in Malmö and the USA.

Do you want to be a key player in a growing, international organization where continuous improvement and patient safety are core values? We are now looking for an experienced and engaged Senior QP Specialist who can contribute to Sever Pharma Solutions' continued growth and is ready to share their knowledge to foster further development and strengthen the quality culture in a changing organization.

The Quality Department you will be joining consists of approximately 50 people, and you will report directly to the VP Director of Quality. You will also collaborate closely with another experienced QP.

About the Role

As a QP, you hold a central and independent role with responsibility for ensuring that manufactured medicinal products meet current GMP requirements, regulatory standards, and internal quality standards before certification and release.

The role involves close collaboration with QA, QC, Production, and other cross-functional groups within the organization.

Your Responsibilities

• Certify and release manufactured medicinal batches in accordance with current 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 those 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 hold a Master's degree in Pharmacy, Chemistry, Biomedicine, or a similar field.
• You have several years of experience as a Quality Assurance specialist, preferably with experience in other quality-related tasks in a GMP-regulated environment.
• You are a QP certified by the Swedish Medical Products Agency and have several years of experience in the international pharmaceutical industry, meeting the Swedish Medical Products Agency's standard HSLF-FS 2021:102.
• You have an agile working style, can prioritize your tasks effectively, and are a clear and effective communicator.
• Previous experience in sterile manufacturing within the pharmaceutical industry is an advantage.
• You speak and write Swedish and English fluently.

As a person, you are confident, accustomed to working independently, and capable of making informed decisions based on your knowledge and experience. You drive your projects efficiently with a focus on continuous improvement. You have excellent teamwork skills and integrity in your role. You thrive in a developmental environment where change and improvement are part of daily life. You are meticulous, structured, and possess a strong quality awareness that permeates your actions. You will be an important part of a very friendly team in an stimulating environment where you will be involved in new development projects that often materialize into state-of-the-art medicines.

We look forward to telling you more about the role and Sever Pharma Solutions! Do not hesitate to contact us for more information or to answer your questions. We will review applications on an ongoing basis. Warmly welcome!