STABILITY RESEARCH CHEMIST (M/F) (H/F)

La mission

Context of the mission: During the development phase of a drug product, the stability study plays a crucial role as it makes it possible to define the shelf life of the product and ensure the quality and safety for our patient. The analytical chemistry and stability laboratory of renal care is looking for a research chemist to complete the current team located in Castlebar, Ireland. The new team member will support the stability study for Vantive peritoneal Dialysis (PD) portfolio for a period of 12-24 months Details of the mission: The goal of the stability study is to discover and observe the behaviour of the product overtime in particular the degradation of the active ingredients present in the solution. The objective is to provide evidence that the quality of the drug remains within the defined or required standards throughout its shelf life and under the influence of a variety of environmental factors such as temperature, humidity and light based on the country’s legislations. Our GMP laboratory is able to perform all the physical, chemical and physiochemical testing. The team is among many other responsibilities and competencies, performing the dosage of active ingredients and impurities, identification of particulate contamination, motoring of degradation products. The choice of the correct parameters to be analysed as well as suitable analytical methods are the basis for meaningful and convincing data. Role and responsibilities: Working within the QA Chemistry team to ensure compliance to Chemistry processes and procedures and is responsible for, but not limited to. • Co-ordination of Stability Study Chapter VI program • Weighing & Sampling of Stability studies • Generation of reports for Stability Studies • Co-ordination of samples to the relevant labs • Compiling data and reviewing data for each stability study • Generation and approval of Annual Product Code review • Generating Temperature and Humidity graphs from Eurotherm software on a monthly Basis. • Monthly Maintenance Activities • Liase with and support on going projects • Liase with and co-ordinate with external service suppliers Benefits to join your team: In addition to the above the chemist role will involve: • Analysis of samples from various phases of the manufacturing process • Interpret data and meet strict guidelines on documentation when recording data • Report analytical results • Experience in a GMP environment and 6S laboratories in a pharmaceutical industry • Develop techniques for the analysis of drug products and chemicals • Work collaboratively in cross-functional teams • Liaise with chemists and production personnel to ensure compliance and efficiencies are met. • Be aware of, and keep up to date with, health and safety issues • Validate methods and equipment. • Support other activities within the Quality department as assigned by the Quality Manager. • Support the generation and approval of Quality Reviews and Annual Product Quality Reviews • Identify continuous improvement and collaboration opportunities, promoting development and implementation of quality data and reports for improvement and optimization of business processes / results. • Support the batch release process • Support the QA dept in the preparation for and during inspections. • Support new product introductions from a QA perspective.