QA Specialist – GMP & Extemporaneous Pharmacy

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 operations in Sollentuna. With us, you'll work closely with operations and help develop quality processes in personalized pharmaceutical manufacturing, extemporaneous pharmacy, 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 efforts and work closely with pharmacists, production, development, and management. Your responsibilities will include: development and management of quality systems working with GMP and regulatory requirements for pharmaceutical manufacturing preparing, 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 supplier assessments and quality agreements training personnel on GMP and quality internal inspections and quality monitoring preparations for and participation in regulatory inspections development and improvement of processes within our extemporaneous pharmacy operations Depending on your experience and competency, the role may develop into greater quality responsibility within the operation. Who We're 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 Pharmacy or in an equivalent quality function within the pharmaceutical industry We'd like to see experience from one or more of the following areas: pharmaceutical manufacturing extemporaneous pharmacy manufacturing 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're a pharmacist or pharmacy technician with manufacturing or extemporaneous pharmacy experience. For candidates with the right education and experience, there may also be an opportunity over time to take on formal GMP responsibility within the operation. About You We believe you're structured, thorough, and quality-conscious, yet 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 separate from the business are willing to identify problems and drive improvements can work independently and take responsibility enjoy short decision-making processes like building structures and processes have high integrity and a strong quality mindset are curious about new work methods and techniques Why AtrimusRx? AtrimusRx works with pharmaceutical supply, drug shortages, licensed medicines, and extemporaneous pharmacy manufacturing. Within our extemporaneous pharmacy operations, we work with personalized pharmaceutical manufacturing and develop new opportunities to produce medicines in strengths and formulations tailored to patient needs. We work with 3D-printing of pharmaceuticals, among other things, which means that 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 become part of a smaller, entrepreneurial company with short decision-making processes and great ambitions. Practical Information Location: Sollentuna Full-time Start Date: By agreement Application Process The recruitment process begins with two tests: A personality test taking approximately 2 minutes. A cognitive test taking 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 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 request that media sales representatives, recruitment consultants, and similar professionals do not contact us.