Description
Duties include:- Provide technical review and approve validation deliverables for Drug Substance/API and Drug Product process validation and characterization, ensuring proper study design and execution.
- Provide guidance to internal customers on best practices, company standards, and health authority expectations for generating and executing process characterization validation protocols and reports.
- Review and approve validation documentation.
- Follow cGMP regulations and Genentech company policies, standards, and procedures.
- Apply advanced theory, technical principles, expert judgment, and cross-functional expertise to independently address process validation issues.
- Notify Management of potential quality or regulatory issues that may affect product quality or regulatory compliance.
Education:
- B.A., B.S., M.S., Ph.D. degree (preferably in Life Science)
Please be in contact as soon as possible for this urgent position.
To find out more about Real please visit www.realstaffing.com