QA Responsible Person, GDP

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🕒 May 9

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TFS HealthScience - Contract Research Organization

WebsiteLinkedInAll Job Openings

501 - 1000 employees

Founded 2007

🧬 Biotechnology

💊 Pharmaceuticals

⚕️ Healthcare Insurance

Biotechnology • Pharmaceuticals • Healthcare Insurance

TFS HealthScience is a leading global Contract Research Organization (CRO) that partners with biotechnology and pharmaceutical companies to advance clinical development. They offer a wide range of solutions including phase I-III clinical development, real-world evidence (Phase IV) studies, and strategic resourcing solutions. TFS HealthScience specializes in multiple therapeutic areas such as dermatology, internal medicine, neuroscience, oncology and hematology, ophthalmology, pediatrics, rare diseases, and orphan drugs. They aim to bring treatments to patients faster by combining their full-service capabilities and global reach with the flexibility and personalized approach of a mid-size CRO.

📋 Description

• 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.

🎯 Requirements

• 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.

🏖️ Benefits

• Opportunities for personal and professional growth in a rewarding environment. • Join a team that values collaboration, quality, and making a difference in the lives of patients. • Core values of Trust, Quality, Passion, Flexibility, and Sustainability guide decisions and shape culture.