Młodszy Specjalista / Młodsza Specjalistka Zapewnienia Jakości w Obszarze API
Core
Ensuring GMP compliance and managing quality processes for API manufacturing within a CDMO environment.
Role type
Junior Quality Assurance Specialist (Pharmaceuticals)
Builds
Pharmaceutical API products for CDMO clients
Domain
Pharmaceuticals / Quality Assurance
Required skills
GMP knowledge, pharmaceutical manufacturing technology, CAPA management, change control, product quality reviews, batch record analysis, quality documentation preparation, audit support, client communication in English
Preferred skills
Quality Control experience, MS Office proficiency
Responsibilities
Monitor GMP implementation in API-related organizational units, lead and support quality processes including CAPA, change controls, and product quality reviews, analyze and evaluate batch production reports for active substances, prepare and update quality documentation, collaborate with Production and Quality Control departments, support preparation of production areas for audits and inspections, prepare responses to audit findings in English, participate in project meetings and teleconferences with CDMO clients, handle client inquiries in the quality area including preparing statements and coordinating quality agreement reviews
Seniority
Junior, hands-on IC