Qualifed Person Verification Support - Mont-Saint-Guibert, België - Unique

Unique

Geverifieerd bedrijf

Mont-Saint-Guibert, België

1 week geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

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.

Profil

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 fastpaced 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)

Offre

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.

Entreprise

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.