QA Responsible Person, GDP
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Job Description
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.
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.
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.
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