Quality Systems Specialist (GMP)

About the position

About this role TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies across development and manufacturing. Our expertise includes full-service capabilities, resourcing, and Functional Service (FSP) solutions. The Quality Systems Specialist (GMP) is responsible for supporting and maintaining quality systems within a GMP-regulated pharmaceutical manufacturing environment. This includes ensuring compliance through audit activities, CAPA management, and effective quality system processes. As part of our SRS/FSP team, you will be dedicated to one sponsor, a global pharmaceutical company operating within a GMP-regulated manufacturing environment. Contract: 3-month consultancy Key Responsibilities Support and maintain Quality Management System (QMS) activities in line with GMP requirements Manage and follow up on CAPAs, ensuring timely closure and effectiveness Perform and support internal and supplier audits Support supplier qualification and ongoing supplier management activities Maintain GMP documentation, including document control and training records Participate in change control processes and ensure compliance with internal procedures Support GMP training management activities Collaborate with cross-functional teams to ensure quality and compliance standards Qualifications Bachelor’s degree in Life Sciences or a related field Minimum 3 years of experience within Quality Assurance in a GMP environment Strong knowledge of GMP regulations and quality systems Experience with CAPA management and audit activities (internal and/or supplier audits) Experience with document control, change control, and training management Experience within pharmaceutical manufacturing (injectables or sterile environment is a plus) Strong communication skills in English (written and spoken) Ability to work independently and manage multiple priorities What We Offer We provide opportunities for personal and professional growth in a rewarding environment. You will join a team that values collaboration, quality, and making a difference in the lives of patients. Our core values of Trust, Quality, Passion, Flexibility, and Sustainability guide our decisions and shape our culture. By aligning on these values, we foster collaboration, innovation, and a shared commitment to excellence. Together, we make a difference. A Bit More About Us Our journey began over 30 years ago in Sweden, in the city of Lund. As a full-service global CRO, we build solution-driven teams working toward a healthier future. Bringing together over 600 professionals, TFS delivers tailored clinical research and resourcing services in more than 50 countries, supporting both clinical development and GMP-regulated manufacturing environments across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.

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