QA Specialist – GMP & Extemporaneous

AtrimusRX AB · plný úvazek

Hammarbacken 6A, Sollentuna, Švédsko

Do you want to work with quality in an operation where pharmaceutical manufacturing, innovation, and regulatory requirements meet? AtrimusRx is seeking a QA Specialist for our growing extemporaneous pharmacy operation in Sollentuna. With us, you'll work close to the operations 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 isn't just about managing 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 will collaborate 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 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 staff on GMP and quality internal audits and quality monitoring preparations for and participation in regulatory inspections development and improvement of processes within our extemporaneous operation Depending on your experience and qualifications, 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 manufacturing or in a corresponding quality function in the pharmaceutical industry We'd particularly like to see experience in 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're 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 to take on formal GMP responsibility within the operation over time. About you We believe you are structured, thorough, and quality-conscious, but also pragmatic and solution-oriented. You need to understand both regulatory requirements and the practical operations behind them. We especially appreciate people who: view quality as a support for operations, not as an administrative function on the side are willing 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, drug shortages, licensed medicines, and extemporaneous manufacturing. Within our extemporaneous operation, we work with personalized pharmaceutical manufacturing and develop new opportunities 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 issues 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 smaller, entrepreneurial company with short decision-making paths and great ambitions. Practical information Location: Sollentuna Scope: Full-time Start date: As agreed 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 will be 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. Accuracy, attention to detail, and the ability to follow instructions are crucial qualities for this position. The application process therefore forms part of our initial selection. Selection and interviews take place on an ongoing basis. The position may be filled before the final application deadline. We ask that you do not contact media sales representatives, recruitment consultants, or similar.