Astek Jobs in Usa

Astek is strengthening its teams of QA Specialists.

Description :

Quality Assurance for Clinical Supply & Cold Chain, supporting the review and approval of GDP documentation generated in the context of supplying products for clinical studies.

Main tasks :

• Review of Supply Flow in line with clinical logistics strategy and qualified status of providers used
• Review of feasibility analysis of transfers between commercial sites, technical research and development GMP department, and its CMOs or between clinical sites to ensure quality attributes of products received and compliance of providers used
• 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 Release of batches prior to shipment to clinical sites
• Assessment of temperature excursions during storage or distribution of products for clinical studies

Required skills :

• 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
• Master's degree in Sciences/Engineering/Bioengineering