Specjalista Operacyjnego Zapewnienia Jakości
Core
Oversee compliance of pharmaceutical packaging processes with GMP, Pharmaceutical Law, and internal Quality Management System requirements.
Role type
Operational Quality Assurance Specialist
Builds
Pharmaceutical packaging processes
Domain
Pharmaceutical industry / Quality Assurance
Required skills
GMP knowledge, Pharmaceutical Law knowledge, Deviation investigation, CAPA management, Change control, Risk assessment, Validation support, Cleaning validation, Room and equipment qualification, Internal/Client/Regulatory audit participation
Preferred skills
SAP systems, MS Office, English (B1/B2)
Technologies
SAP, MS Office
Responsibilities
Review and approve quality documentation, procedures, and instructions for packaging processes; Participate in change control processes; Lead and approve actions related to deviations, complaints, and CAPA; Review production documentation for regulatory and GMP compliance; Support risk quality analyses; Support process validation, cleaning, and qualification of rooms and equipment; Participate in internal, client, and regulatory inspections
