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Qualified Person - Sterile and Non-Sterile - Netherlands Based
146109
Posted:
27/06/2024th
27/06/2024
- 90000 EUR - 100000 EUR
- Voorschoten, Netherlands
- Permanent
Qualified Person - Sterile & Non-Sterile Experience Required
My client is a leading producer of Inhaled Aesthetics and a global player in Hospital Generics. They are looking for a Qualified Person with sterile and non-sterile experience to join their base in the Netherlands.
The Role:
The primary legal responsibility of the Qualified Person is to certify batches of Medicinal Product
prior to release for sale and placing on the market (Human and Veterinary Medicinal Products) or prior to use in a Clinical Trial (Human Medicinal Products only).
The Qualified Person is responsible for the direct supervision of the company and is expected to be regularly present at the facilities where the activities take place in order to overview the organisation and all activities to ensure compliance with the legal requirements at any time.
Qualification Requirements
roisin@peoplewithchemistry.com
02030196002
My client is a leading producer of Inhaled Aesthetics and a global player in Hospital Generics. They are looking for a Qualified Person with sterile and non-sterile experience to join their base in the Netherlands.
The Role:
The primary legal responsibility of the Qualified Person is to certify batches of Medicinal Product
prior to release for sale and placing on the market (Human and Veterinary Medicinal Products) or prior to use in a Clinical Trial (Human Medicinal Products only).
The Qualified Person is responsible for the direct supervision of the company and is expected to be regularly present at the facilities where the activities take place in order to overview the organisation and all activities to ensure compliance with the legal requirements at any time.
Qualification Requirements
- A minimum of 2 years' experience working as a Qualified Person (QP)
- Eligible to act as a Qualified Person (QP) under EC/2001/83 Directive as updated
- Experience acting as a certifying QP for solid unit dose products
- Experience acting as certifying QP for IMPs
- Some experience within quality assurance for sterile products
- Some experience within quality assurance for narcotic products
- Minimum C-1 level in Dutch and in English
- Office based working environment with working from home flexibility
- Some travel for audits mainly in the EU, but occasionally globally
- The position will report into the Lead QP (NL)
roisin@peoplewithchemistry.com
02030196002
Roisin Heekin
Resourcer