Absolwent Kierunków Farmaceutycznych, Biotechnologicznych, Chemicznych lub Biologicznych Ścieżka Rozwoju do QP - Qualified Person
Core
Support the Pharmaceutical Quality System and regulatory processes for medicinal gases, preparing documentation for Qualified Person (QP) release.
Role type
Junior Quality Assurance Specialist (Pharmaceutical)
Builds
Pharmaceutical quality systems and regulatory compliance for medicinal gases
Domain
Life Sciences / Pharmaceutical Manufacturing / Industrial Gases
Required skills
Analytical thinking, documentation management, accuracy, responsibility, organizational skills
Preferred skills
GMP knowledge, Pharmaceutical Law knowledge, Quality/Production/Registration experience, Medicinal gas production processes, QP qualification requirements
Technologies
GMP, Pharmaceutical Law
Responsibilities
Support Pharmaceutical Quality System operations per GMP, Maintain and develop quality management systems, Participate in medicinal product marketing authorization processes, Prepare and review quality and regulatory documentation, Manage change control, deviations, complaints, and CAPA, Collaborate with Production, Quality Control, and Regulatory Affairs, Participate in internal audits, supplier audits, and regulatory inspections, Prepare production and quality documentation for QP assessment, Support QP in product batch release and certification, Monitor changes in medicinal product legal and regulatory requirements
Seniority
Entry-level, development track
