QA Associate

Location Netherlands
Discipline: Biotechnology
Contact name: Beata Wydurska

Contact email: b.wydurska@panda-int.com
Job ref: 19277
Published: about 1 month ago
We are looking for an Associate QA for our big biotech client in Breda.

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)
If interested, please send your CV to b.wydurska@panda-int.com or contact Beata Wydurska at +31 20 20 44 502.