Specjalista ds. Dokumentacji QC / GMP (biofarmacja) - k/m
Core
Preparing, updating, and verifying quality control (QC) documentation to ensure compliance with GMP regulations in a pharmaceutical/biopharmaceutical laboratory environment.
Role type
QC Documentation Specialist (GMP)
Builds
Laboratory documentation, validation protocols, registration dossiers, and analytical method transfer documents for pharmaceutical clients.
Domain
Biopharmaceuticals / Quality Control
Required skills
GMP compliance knowledge, laboratory analysis execution, data analysis, problem-solving, document management, project implementation support
Preferred skills
Experience in biotechnology, biology, analytics, pharmacy, or related fields
Technologies
GMP documentation systems, laboratory information management systems (implied by context)
Responsibilities
Develop and update QC department documentation, prepare procedures and specifications, support validation and method transfer projects, assist in registration documentation, support audits and inspections, collaborate with laboratories, monitor document circulation, participate in new product/process projects
Seniority
Mid-level, hands-on specialist
