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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.
Types of Audits
- cGMP
- ISO 9001
- GDPR
- Trackwise, World Excel, power point
![Frame 1000005946 Frame 1000005946](https://apotechconsulting.com/wp-content/uploads/Frame-1000005946.png)
Scope of work
![Done Done](https://apotechconsulting.com/wp-content/uploads/Done.png)
Remote batch certification and release of medicinal products
![Done Done](https://apotechconsulting.com/wp-content/uploads/Done.png)
Provide regulatory expertise as requested
![Done Done](https://apotechconsulting.com/wp-content/uploads/Done.png)
Review Marketing Authorisation variations
![Done Done](https://apotechconsulting.com/wp-content/uploads/Done.png)
Perform training with impacted personnel on SOPs
![Done Done](https://apotechconsulting.com/wp-content/uploads/Done.png)
Perform quality and regulatory activities as required by internal SOPs
![Done Done](https://apotechconsulting.com/wp-content/uploads/Done.png)
Liaise with HPRA & EMA
![Done Done](https://apotechconsulting.com/wp-content/uploads/Done.png)
Review and approval of annual Product Quality Review
![Done Done](https://apotechconsulting.com/wp-content/uploads/Done.png)
Review and approval of Annual Product Quality
![Done Done](https://apotechconsulting.com/wp-content/uploads/Done.png)
Perform external audits and participate in internal audits when applicable
![Have a project in mind_ Let’s work together! Have a project in mind_ Let’s work together!](https://apotechconsulting.com/wp-content/uploads/Have-a-project-in-mind_-Lets-work-together.png)
Key numbers
![Management Management](https://apotechconsulting.com/wp-content/uploads/Management.png)
Team
0,4 FTE
![Charity Charity](https://apotechconsulting.com/wp-content/uploads/Charity.png)
Location
Remote
![Combo Chart Combo Chart](https://apotechconsulting.com/wp-content/uploads/Combo-Chart.png)
Length
18 months
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Type
Time and Material