Job - Skilled - Recruitment Solutions GmbH
Aufgaben
- Supporting Projects: Assist the Technical Project Leader throughout the drug substance lifecycle, spanning development, scale-up, validation, and commercialization.
- Team Collaboration: Work closely with internal CMC teams to ensure comprehensive technical development and adherence to regulatory standards.
- Managing Procurement: Validate Requests for Proposals, process purchase requisitions, and oversee Purchase Orders (PO) to facilitate smooth procurement operations.
- Overseeing Supply Chain: Select vendors for packaging partnerships, conduct packaging validation, and manage logistics to ensure timely delivery. Responsible for payment schedules, invoice reconciliation, and contract management across global suppliers.
- Supporting Clinical Trials: Monitor and maintain regulatory documentation for global clinical trials. Assist in preparing Briefing Books for Health Authority meetings and manage timelines and responses to quality inquiries.
- Regulatory Oversight: Collaborate with the CMC department to review and refine regulatory documentation for compliance and efficacy.
Qualifikationen
- Master's Degree in Chemistry or a related field.
- Minimum 5 years of experience in the pharmaceutical industry, with a background in technical regulatory affairs, R&D, product development, or manufacturing.
- Familiarity with ICH guidelines and a foundational understanding of drug substance/product development, manufacturing processes, quality control, and regulatory compliance.
- Proficiency in commercial packaging activities, including validation and artwork creation.
- Experience in collaborating with and overseeing Contract Manufacturing Organizations (CMOs).
À propos de l'entreprise
