Vacant job

Job Description

Do you have a problem-solving and investigative approach? Do you enjoy making decisions and thereby contributing to ensuring that pharmaceuticals and medical devices meet the right quality and fulfill set requirements? Then a role in QA is right for you! It involves independent work, broad tasks, and great opportunities for development and personal learning. The role requires strong commitment, determination, curiosity, and integrity.  

Randstad Life Sciences Uppsala is currently seeking specialists in QA - Quality Assurance who have experience working under quality systems, primarily ISO9001 and ISO13485, for upcoming consulting assignments with our clients. The assignments may involve work with review and release of pharmaceuticals, medical devices, and raw materials. Furthermore, tasks such as deviation management, approval of specifications, methods, and production protocols may be included. 

Randstad Life Sciences specializes in natural sciences. As a consultant with us, you will receive a competitive salary, benefits, and collective agreement terms. Your consultant manager, who is always close at hand, ensures that you receive varied and developing assignments at different companies. As part of your employment, you will also have the opportunity to develop your skills and/or take additional leave after you have been with us for a while. At Randstad Life Sciences, your personal development is in focus, and you are offered a large network and many social activities.

Responsibilities

• Establish, maintain, and improve quality systems related to ISO9001, ISO13485, and quality requirements for the development organization

• Issue and update quality documentation during product development

• Quality review and approval of documents related to ISO9001, ISO13485, and approval of product development documentation

• Prepare for the release of purchased materials to production 

• Compile quality documentation 

• Support risk management in drug development and the development of medical devices

• Collaborate with other departments (e.g., QC, packaging development, formulation, analytical development)

• Participate in training of personnel within the department

• Support during internal and external regulatory inspections

• Participate in continuous improvement efforts related to quality

Qualifications

• Relevant education (MSc or PhD) in biomedicine, molecular biology, microbiology, chemistry, pharmacology

• 2-3 years of experience in quality work and knowledge of regulatory requirements from the pharmaceutical industry, it is a merit if you have participated in/conducted inspections

• Good knowledge and experience in ISO9001 and ISO13485 as well as other regulations relevant to pharmaceuticals and medical devices

• Previous experience in GMP work is a merit

• Experience in pharmaceutical or technical product development and risk management

• Experience in the release of pharmaceuticals and materials to production

• Very good knowledge of Swedish and English, and can express yourself fluently in both spoken and written form as documentation primarily occurs in Swedish

About the Company

Randstad

At Randstad, we know that everyone has a place in the labor market. With operations across the country and in all areas of expertise, we help people find a job that feels good, where they have the opportunity to grow, develop, and reach their full potential.

With nearly 600,000 employees in 38 countries, Randstad is a world leader in HR services, aiming to be the world's leading and most appreciated partner in the labor market. By combining our passion for people with the power of today's technology, we help people and companies achieve their full potential. We call it Human Forward.