QA Specialist – GMP & Extemporaneous

AtrimusRX AB · Full-time

Hammarbacken 6A, Sollentuna, Sweden

Do you want to work with quality in an operation where pharmaceutical manufacturing, innovation, and regulatory requirements meet? AtrimusRx is looking for a QA Specialist for our growing extemporaneous pharmacy operation in Sollentuna. With us, you'll work close to the operation and help develop quality processes within personalized pharmaceutical manufacturing, extemporaneous preparation, and new manufacturing techniques. This is a role for someone with QA and GMP experience who wants to work in an environment where quality is not just about maintaining existing processes, but also about developing them. About the Role As a QA Specialist, you'll be a central part of our quality work and collaborate closely with pharmacists, production, development, and management. Your responsibilities will include: developing and maintaining quality systems working with GMP and regulatory requirements for pharmaceutical manufacturing creating, reviewing, and updating SOPs and other quality documentation deviation management, CAPA, and change control risk assessments and Quality Risk Management qualification and validation of equipment, processes, and methods review of manufacturing and quality documentation supplier assessments and quality agreements training personnel on GMP and quality internal inspections and quality monitoring preparations for and participation in regulatory inspections developing and improving processes within our extemporaneous operation Depending on your experience and expertise, the role can develop into greater quality responsibility within the operation. Who Are We Looking For? We are looking for someone with relevant QA and GMP experience in pharmaceutical manufacturing. You might currently work as: QA Specialist Senior QA Specialist QA Manager Validation Specialist Quality Responsible Production Pharmacist Pharmacist in extemporaneous manufacturing or in a similar quality function within the pharmaceutical industry We would appreciate if you have experience from one or more of the following areas: pharmaceutical manufacturing extemporaneous manufacturing pharmaceutical industry hospital pharmacy with manufacturing validation and qualification deviation management and CAPA change control Quality Risk Management regulatory inspections working with quality systems in regulated operations Pharmaceutical education is a merit, especially if you are a pharmacist or pharmacy technician with experience in pharmaceutical manufacturing or extemporaneous preparation. For candidates with the right education and experience, there may also be an opportunity in the long term to assume formal GMP responsibility within the operation. About You We believe you are structured, thorough, and quality-conscious, yet pragmatic and solution-oriented. You need to be able to understand both regulatory requirements and the practical operations behind them. We especially appreciate people who: view quality as a support for the operation, not as an administrative function on the side are willing to identify problems and drive improvements can work independently and take responsibility enjoy short decision-making paths like building structures and processes have high integrity and a strong quality mindset are curious about new ways of working and techniques Why AtrimusRx? AtrimusRx works with pharmaceutical supply, drug shortages, licensed medicines, and extemporaneous manufacturing. Within our extemporaneous operation, we work with personalized pharmaceutical manufacturing and develop new ways to manufacture medicines in strengths and formulations adapted to the patient's needs. We work with, among other things, 3D printing of medicines, which means that quality and regulatory matters are an integrated part of both development and manufacturing. With us, you'll therefore have the opportunity to work in an operation where QA is closely linked to development, production, and innovation. You'll be part of a small and entrepreneurial company with short decision-making paths and big ambitions. Practical Information Location: Sollentuna Scope: Full-time Start Date: By agreement Application Process The recruitment process begins with two tests: A personality test that takes approximately 2 minutes. A cognitive test that takes approximately 12 minutes. The second test is sent 24 hours after the first test is completed. Once both tests are completed, send your CV to [email protected]. All steps must be completed in the specified order. Applications that do not follow this procedure will not be considered. Thoroughness, attention to detail, and the ability to follow instructions are critical qualities for this position. The application process therefore forms part of our initial screening. Selection and interviews are ongoing. The position may be filled before the final application deadline. We do not accept contact from media sales, recruitment consultants, and similar.