QA - Responsible Person (GDP)

Job description

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 devi...