Quality Systems Specialist (GMP)
Share
Job Location:
Monthly Salary:
Posted on:
2 hours ago
Vacancies:
1 Vacancy
Job Summary
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
Bachelors 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.
Key Skills
About Company
TFS HealthScience is a global, mid-sized contract research organization (CRO) partnering with biotechnology and pharmaceutical companies across the full clinical development lifecycle. Our expertise spans full-service clinical development, project-based support, strategic resourcing, ... View more
