QA Responsible Person, GDP

TFS HealthScience - Contract Research Organization

Part-time QA Responsible Person ensuring compliance with GDP/GMP regulations in local pharmaceutical batch releases. Working with global teams and maintaining oversight of quality systems in the Czech Republic.

Posted 5/9/2026contractRemote • CzechiaJuniorWebsite

About the role

Key responsibilities & impact

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

What you’ll need

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

Comp & perks

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.

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

QA experiencebatch documentation reviewcertification of batch documentationknowledge of GDP regulationsknowledge of GMP requirementsexperience with sterile manufacturingexperience with oncology productsexperience with CAR-T therapiesquality management activitiesdeviations management

Soft Skills

attention to detailaccountabilityindependent workcollaborationcommunication

Certifications

Qualified Pharmacist