Unique Wavre

Offre d'emploi : Qualifed Person Verification Support

Recruteur
Unique Wavre
Région
MONT-SAINT-GUIBERT
Publication
jeudi 19 janvier 2023
Date limite
dimanche 19 février 2023
Réf
UNQ-BE
Contact
Unique Wavre Office
Niveau d'expérience
2 à 5 ans d'expérience
Type de contrat
CDI
Temps de travail
Temps plein

Our client is a fast growing company active in the pharmaceutical sector and located in the heart of Walloon Brabant in a very easy access area.​



Job Description

ROLE

  • Support the compilation and verification of documentation provided relating to the requirements of MHRA guidance for the importing of IMPs into Great Britain from approved countries. Verification will involve the review of documentation provided by the clinical trial study sponsor and /or external contract giver, as applicable, to verify a product batch(es) complies with requirements.
  • Coordination between the Project Management Team, to maintain a comprehensive list of batches requiring UK QP verification, and manage the priorities based upon patient and commercial need. Work with the UK QP verification group to ensure these priorities are clear.
  • Engage with clients, liaise with the clinical trial study sponsor or respective delegate at a CRO, and internally within the society and /or external contract giver, as applicable, to ensure a complete documentation set is available to support UK QP verification activities. Ensure that wherever possible, that documentation is “right first time” to make the verification process efficient.
  • Work with the UK Quality Specialist in maintaining a database of documentation provided for UK QP verification per study.
  • Performing UK QP verification activities (as delegee) for batches requiring UK QP verification.
  • Performs other related job duties or responsibilities as assigned.



Job Requirements

REQUIREMENTS

  • Bachelor’s degree or equivalent knowledge or an equivalent combination of education and experience to successfully perform the key responsibilities of the job
  • Knowledge of applicable Clinical Trial Guidance, especially the MHRA rules for importing investigational medicinal products into Great Britain from approved countries
  • Experience of working with clinical trial regulatory documentation is preferable
  • Related work experience working with the principles and practices involved in GCP and Clinical Trial Management
  • Must possess a detailed and proactive approach to management in problem solving of daily operations
  • Excellent interpersonal communication and listening skills
  • Superior time management skills for working within a fast-paced environment
  • Able to critically evaluate situations and adapt quickly in making timely and independent decisions
  • Must demonstrate a high level of initiative and the ability to work well independently and as a team member
  • Confidentiality of all clients proprietary and pharmaceutical related information is essential
  • Strong awareness of ownership of assigned projects and responsibilities
  • Cultural awareness while working across regions with internal or external team members
  • Computer skills : excellent Microsoft Office Products: Word, Excel, Outlook, PowerPoint
  • Language skills : Fluent in French and English (German is a big asset)



Salary and Benefits

Offer: Our client offers an attractive salary with extra-legal benefits. The opportunity to become part of a dynamic team and the possibility to develop your skills. A permanent contract in a challenging international environment.

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