Prepare clinical regulatory documents for public disclosure, including anonymization of personal data and redaction of commercially confidential information
Experience in environment monitoring, QMS, routine & non routine analysis, PET, sterility, BET & water testing. Experience in injectable / ophthalmic products.
Support a discipline and or provide a service individually or within a team of associates. May provide functional expertise to Line Unit and other QA Units in area of responsibility
Demonstrated understanding of pharmaceutical manufacturing, analytical testing, and quality assurance. managing CMC Regulatory submissions for small molecules/vaccines/biologics