Batch Release as EU Qualified Person
Introduction
Our client is a vertically integrated company in chemical synthesis and manufacturing of generic Active Pharmaceutical Ingredients and Drug Products.
Standards and references
- cGMP
- ISO 9001
- GDPR
- Trackwise, World Excel, power point
Scope of work
Remote batch certification and release of medicinal products
Provide regulatory expertise as requested
Review Marketing Authorisation variations
Perform training with impacted personnel on SOPs
Perform quality and regulatory activities as required by internal SOPs
Liaise with HPRA & EMA
Review and approval of annual Product Quality Review
Review and approval of Annual Product Quality
Perform external audits and participate in internal audits when applicable
Key numbers
Team
0,4 FTE
Location
Remote
Length
18 months
Type
Time and Material
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