Sr. Associate QA clinical manufacturing/clinical supply chain

Location Netherlands
Discipline: Biotechnology
Job type: Permanent/Temporary
Contact name: Beata Wydurska

Contact email: b.wydurska@panda-int.com
Job ref: 19000
Published: about 2 months ago

We are searching for a Sr. Associate QA clinical manufacturing/clinical supply chain for one of our top Biopharma clients in Breda, NL!

Responsibilities
• Responsible for batch review to support QP batch certification of Investigational Medicinal Product in compliance with EU and international regulations
• Compliance review and approval of clinical label artwork
• Responsible for assessment of temperature excursions during transport and at clinical sites
• Assist in resolution of compliance and quality issues related to the manufacturing and transport of clinical products
• Review and approve minor deviations ensuring all procedural requirements are met
• Owning and generating operational SOP’s and Work Instructions
• Review of SOP’s ensuring that Corporate, Site and Regulatory requirements are met
• Responsible for preparation of monthly metrics
• Identify issues and work cross functionally to ensure a solution


Qualifications
• MBO or Bachelor’s degree in Life Sciences or related field or the equivalent combination of education and/or experience
• Typically 3 years of related Quality Assurance or manufacturing experience in the pharmaceutical or medical device industry with experience in batch record review, investigations and analytical testing
• Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) and/or Good Clinical Practice (GCP) knowledge
• Fluent in English


Practicalities
  • 40 hours/week
  • Contract: 1 year (extension is expected)
  • Location: Breda
  • Start date: July 2022
If interested, please send your CV to b.wydurska@panda-int.com or contact Beata Wydurska at +31 20 20 44 502.