QA - Responsible Person (GDP)

Aout 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.

This is a part-time role (0.5 FTE) directed at Freelance individuals based in Czech Republic.

As part of our SRS/FSP team, you will be dedicated to one sponsor, that is an industry leader within its therapeutic area.

Key Responsibilities

• Act as the QA Responsible Person (RP) for local batch release of medicinal products in the Czech Republic, ensuring compliance with GDP/GMP requirements.

• Perform review and certification of batch documentation for Gilead products, including solid dosage forms (tablets), sterile oncology products, and CAR-T therapies (patient-specific release).

• Ensure compliance with local regulatory requirements and maintain oversight of quality systems and processes.

• Collaborate with global QA, manufacturing sites, and supply chain teams to ensure timely and compliant product release.

• Support and maintain quality management activities, including deviations, CAPAs, change controls, and inspections readiness.

Qualifications

• Qualified Pharmacist eligible to act as Responsible Person in the Czech Republic (must be based in Czech Republic).

• Minimum 1 year of QA experience within the pharmaceutical industry.

• Knowledge of GDP regulations and batch release processes.

• Experience with sterile manufacturing, oncology products, or advanced therapies (e.g., CAR-T) is highly desirable.

• Ability to work independently in a part-time capacity (0.3–0.5 FTE) with strong attention to detail and accountability.

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 services in more than 50 countries, offering flexible clinical development and strategic resourcing solutions across key therapeutic areas including Dermatology, Neuroscience, Oncology, and Ophthalmology.