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Qualified Person (QP)

  1. Norway
  1. Contract
Competitive
26954
  1. Compliance / Quality Assurance
Date Posted04 Jun 2021
Qualified Person (QP) opportunity with a global bio-tech manufacturing organisation based in South Norway. 

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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