Qualified Person (QP)
- Norway
- Contract
- Compliance / Quality Assurance
This vacancy has now expired
Our bio-tech client is currently in the process of investing significantly in their manufacturing programme. They’re currently looking for a QP to join them on this exciting journey. The ideal candidate will be able to partner with existing QPs and take over event investigations (OOS, Deviations, CAPAs) helping identify root causes and implement corrective actions. In return the business will offer competitive rates along side working for a global market player.
A Qualified Person must ensure that each batch has been manufactured and checked in compliance with the laws in force in that Member State and in accordance with the requirements of the marketing authorisation and the restriction for a Qualified Person in Good Manufacturing Practice.
Main responsibility
- (In accordance and guidelines of EC GMP, the laws of the Member State, or GMP of third country recognition agreement, and any other relevant legal requirement)
- Defined batch of finished products must be certified before being released for sale or supply before sale/export.
- Ensure that the batch has been manufactured and checked in accordance with the requirements of its marketing authorisation.
- Reject batches that not confirm to established requirements.
- Ensure all stages through manufacture, including quality control testing, may be conducted in accordance with relevant guidance/laws should be considered when he/she certifies the finished product batch before release for the market. (This must be done through knowledge good manufacturing procedures and confirmations on our quality systems).
- Release finished CE marked products in accordance with internal requirement and any other relevant legal requirement.
If this role interests you, apply today!
The candidate must have the rights to work in the location stated in the job advert.
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I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
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Suraj
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