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Quality Assurance Specialist - Supply

Quality Assurance Specialist - Supply

Keyrus Life ScienceBrussels
30+ dagen geleden
Functieomschrijving

Keyrus Life Science is looking for a new colleague in Supply & Cold Chain Quality team (Q4R&D) to help the review and approval of GDP documentation generated in the context of the supply of products for clinical studies.

Job Description

  • Review of Supply Flow in line with clinical logistics strategy
  • Support feasibility analysis of product transfers between manufacturing facilities, technical research department and / or clinical site.
  • Generation and / or review of cold chain documentation provided to CMOs / CROs to confirm storage conditions and cold chain budget allocated to CMO / CRO activities;
  • Determination of the cold chain budget available at the time of Final Release of batches.Assessment of temperature excursions during storage or distribution of products for clinical studies.

YourProfile :

  • 3 to 5 years of experience in a Quality Assurance environment; ideally in the pharma industry;
  • Knowledge of cGMP, GDP, cold chain, manufacturing operations, clinical trial, product development and regulatory requirements;
  • Need of a good scientific background to understand the objectives of the studies and to interact with both GMP & Clinical operations;
  • Understanding of how clinical trials are set up and run as well as the associated legal and regulatory framework;
  • Good communication skills : ability to listen effectively, communicate complex matters both verbally and in writing, and ask questions that lead to the discovery of root causes;
  • Fluent in French and in English.
  • University degree : Master’s degree in sciences / Engineering e.g. Pharmacist / Master in Sciences / Bio Engineer;

    • What we offer

    Take the chance to join a fast-growing and super dynamic team in Belgium. The Clinical Supply team at Keyrus Life Science is bursting with exciting new projects and is always looking to expand since its beginning. If you want to be part of a big family, grow professionally, and make patients matter, this is the place to be!

    We invest considerable time and resources in training our staff (technical and non-technical courses) to continuously support you in your personal and professional growth. On top of this, you will receive a complete salary package including attractive extra-legal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization…) based on your background and experience.

    Who we are

    Keyrus Life Science is an international Consulting, Contract Research Organization and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence. Our ‘human’ approach to service provision is what differentiates us from our competitors. Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.

    At Keyrus Life Science we’re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently, and reliably, but also with sincerity and genuine care for our clients’ projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better.

    From early- to late-stage drug development, our range of services includes : Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Biostatistics, Medical Writing & Medical Information, Real World evidence services.....