Młodszy Specjalista / Młodsza Specjalistka ds. Zapewnienia Jakości
Core
Junior Quality Assurance Specialist supporting GMP compliance and quality processes for API business units in a CDMO environment.
Role type
Junior Quality Assurance Specialist (API/CDMO)
Domain
Pharmaceutical manufacturing / Quality Assurance
Required skills
Pharmaceutical/Chemical/Biological degree, MS Office proficiency, English communication, GMP knowledge, Quality Assurance/Control experience
Preferred skills
Knowledge of pharmaceutical production technologies, CAPA process experience, Change control experience, Product quality review experience
Responsibilities
Support GMP compliance monitoring in API business units, Participate in quality processes (CAPA, change control, product quality reviews), Verify and evaluate batch production reports, Develop and review quality documentation, Collaborate with Production and Quality Control areas, Prepare production areas for inspections and audits, Prepare responses to audit/inspection reports in English, Participate in project meetings and teleconferences with clients and internal teams, Support clients in quality areas (statements, quality surveys, contract review coordination, client inquiries in English)