QA - Responsible Person (GDP)Verified as a real position

Who we’re looking for

• 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 you’ll do

• 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.

About the position

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.

Benefits

• 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.