Młodszy Specjalista / Młodsza Specjalistka ds. Zapewnienia Jakości
Core
Leading and participating in investigations of quality deviations and non-conformities in the manufacturing process of medicinal products.
Role type
Junior Quality Assurance Specialist (Pharmaceutical Manufacturing)
Builds
Quality management systems and regulatory documentation for medicinal products
Domain
Pharmaceutical industry + Quality Assurance
Required skills
Pharmaceutical/Chemical/Biological degree, Knowledge of Pharmaceutical Law and GMP, English language proficiency, Analytical documentation development, Risk management participation, Change control participation, Product Quality Review (PQR) preparation, GMP inspections
Preferred skills
Teamwork, Self-organization
Technologies
GMP, Pharmaceutical Law
Responsibilities
Lead and participate in investigations of quality deviations and non-conformities in the manufacturing process of medicinal products, Monitor implementation of CAPA actions and participate in quality risk management processes, Develop, update, review and approve Quality Assurance System documentation (procedures, instructions, specifications, analytical documentation), Administer quality documentation created in the facility and received from external entities, Develop and update specifications, test methods and registration documentation for medicinal products and raw materials, Participate in change control processes and review changes in production, warehouse and quality control areas, Participate in Product Quality Review (PQR) process and prepare quality reports, Perform short GMP inspections and assess manufacturing processes within Operational Quality Assurance, Collaborate in maintaining and improving the Quality Assurance System in accordance with GMP and Pharmaceutical Law requirements
