
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