QA Specialist – GMP & Extemporaneous

AtrimusRX AB · Vollzeit

Hammarbacken 6A, Sollentuna, Schweden

Do you want to work with quality in an operation where pharmaceutical manufacturing, innovation, and regulatory requirements converge? AtrimusRx is seeking a QA Specialist for our growing extemporaneous pharmacy operation in Sollentuna. With us, you'll work closely with operations and help develop quality practices in personalized pharmaceutical manufacturing, extemporaneous compounding, and new manufacturing techniques. This is a role for someone with QA and GMP experience who wants to work in an environment where quality isn't just about maintaining existing processes, but also about developing them. About the Role As a QA Specialist, you'll be a key part of our quality efforts and work closely with pharmacists, production, development, and management. Your responsibilities will include: development and maintenance of quality systems working with GMP and regulatory requirements for pharmaceutical manufacturing creating, reviewing, and updating SOPs and other quality documentation deviation handling, CAPA, and change control risk assessments and Quality Risk Management qualification and validation of equipment, processes, and methods review of manufacturing and quality documentation vendor assessments and quality agreements training staff in GMP and quality internal inspections and quality monitoring preparations for and participation in regulatory inspections development and improvement of processes in our extemporaneous operations Depending on your experience and expertise, the role can also develop into greater quality responsibility within the operation. Who Are We Looking For? We're seeking someone with relevant QA and GMP experience in pharmaceutical manufacturing. You may currently work as, for example: QA Specialist Senior QA Specialist QA Manager Validation Specialist Quality Manager Production Pharmacist Pharmacist in extemporaneous compounding or in a corresponding quality function in the pharmaceutical industry We would be pleased if you have experience from one or more of the following areas: pharmaceutical manufacturing extemporaneous compounding pharmaceutical industry hospital pharmacy with manufacturing validation and qualification deviation handling 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 compounding. For candidates with the right education and experience, there may be an opportunity to take on formal GMP responsibility within the operation in the future. As a Person We believe you are structured, thorough, and quality-minded, but also pragmatic and solution-oriented. You need to understand both regulatory requirements and the practical operations behind them. We especially appreciate people who: see quality as a support for operations, not as an administrative function separate from the business dare to identify problems and drive improvements can work independently and take responsibility thrive with short decision-making paths enjoy building structures and processes have high integrity and a strong quality mindset are curious about new working methods and techniques Why AtrimusRx? AtrimusRx works with pharmaceutical supply, medicine shortages, licensed medicines, and extemporaneous compounding. Within our extemporaneous operations, we work with personalized pharmaceutical manufacturing and develop new ways to produce medicines in strengths and formulations tailored to patient needs. We work with, among other things, 3D printing of pharmaceuticals, which means quality and regulatory matters are an integrated part of both development and manufacturing. With us, you'll have the opportunity to work in an operation where QA is closely linked to development, production, and innovation. You'll be part of a smaller, entrepreneurial company with short decision-making paths and great ambitions. Practical Information Location: Sollentuna Full-time Start: 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 is therefore part of our initial screening. Selection and interviews are ongoing. The position may be filled before the final application deadline. We do not welcome contact from media sales representatives, recruitment consultants, and similar.