Quality Assurance Specialist
Job Overview
About this role
TFS HealthScience is a leading global mid-size Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies throughout their entire clinical development journey. Our expertise includes full service capabilities, resourcing and Functional Service (FSP) solutions.
The Quality Assurance Specialist is responsible for independently planning, conducting, and following up on GMP and other GxP audits in accordance with company procedures, applicable regulations, and international guidelines.
As part of our SRS/FSP team, you will be dedicated to one sponsor, a global pharmaceutical/biotech company that is an industry leader in GMP manufacturing and pharmaceutical development.
Key Responsibilities:
Prepare, conduct, and follow up on GMP focused audits including system, vendor, and process audits
Support manufacturing sites and internal teams in preparation for GMP inspections
Facilitate and support sponsor and regulatory audits related to GMP activities
Provide GMP quality assurance advice and guidance to internal and external stakeholders
Contribute to continuous improvement initiatives related to GMP quality systems
Act as trainer and subject matter expert within GMP related training initiatives
Qualifications:
University degree or equivalent relevant industry experience
In depth knowledge of GMP regulations and guidance
Experience within GMP environments such as manufacturing, quality assurance, or quality systems
Three to ten years of GMP auditing experience
Ability to work independently with strong organisational and problem solving skills
What We Offer
We provide a competitive compensation package, comprehensive benefits, and the opportunity for personal and professional growth in a rewarding environment. You’ll be joining a team that values collaboration, innovation, and making a difference in the lives of patients
A Bit More About Us
Our journey began over 27 years ago in Sweden, in the city of Lund. As a full-service, global Contract Research Organization (CRO), we build solution-driven teams working towards a healthier future. Bringing together over 800 professionals, TFS delivers tailored clinical research services in more than 40 countries with flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.
Our core values of Trust, Quality, Passion, Flexibility, and Sustainability are our guiding light serving as the framework for decision-making at all levels of the organization. They assist us in attracting and retaining valuable talent who share our sentiments, resulting in high employee engagement and satisfaction. By aligning on these fundamental values, we cultivate a unified force, geared towards innovation and excellence. This collective effort propels us towards our shared goal and fosters a culture of mutual respect and collaboration. Together we make a difference.