Responsibilities:
Associate shall support activities to maintain the quality system and execute tasks in compliance with Amgen’s Quality Management System, GMP & GDP requirements and any local applicable regulations.
Documentation
Associate shall ensure that:
• documentation is accordingly processed
• records are accurate and up to date
• records are kept according to applicable requirements
Product Complaints and suspected falsified medicinal products
The associate is required to:
• Manage/oversee Product Complaint returns process
• Perform intake of incoming Product Complaints and additional follow-ups with external parties, with different levels of complexity depending on the case
• Follow up with complainants, Quality Complaints Team and third parties when appropriate
• Notify complainants of complaint closure
Activities also include identification of Adverse Events, Medical Information enquiries and brand protection issues as well as potential counterfeit
Requirements:
- Fluency in English, and any additional language as required per the role
- Information and Communication Technologies
- MBO or equivalent in Life Sciences or in Supply Chain & Logistics Management
- A certain level (?1 year) of professional experience
- Knowledge of Quality Assurance principles, Good Manufacturig Practice and Good Distribution Practice
- Strong word processing, database and spreadsheet application skills
Practicalities
- 40 hours/week
- Location: Breda
- Start date: middle of August 2022- middle of August 2023 (extension is expected)