The candidate will join the Quality Control Laboratory, reporting to the QC Quality systems Head in collaboration with other QC technicians and analysts.
Job assigment:
• Implementation of Good Controlled documentation and GMP requirements for analytical methodologies, method transfer and Validation in order to fulfil the analytical requirements of our customers following the clinical development of the Drug Substance and Drug Product.
• Achieving the goals of each project by complying with the timelines agreed with our customers.
• Assuring GMP activities in the PhysicoChemical department.
• Troubleshooting of OOS and deviation in the laboratory.
• Working closely with the analytical development team in order to generate transfer analytical method protocols internally.
• Assure Validation of analytical methods according to ICH guidelines and GMP requirements depending on the intended use of the method.
• Coordination of raw material release and analysis of intermediates, Drug Substances and Drug Products.
• Coordination and support of the stability studies agreed with our customers in collaboration with other technician.
• Supervision of QC physico-chemical analysis done on routine, validation and transfer activities
• Planning of the activities to be performed in the physico-chemical area of the Quality Control laboratory in collaboration with other technicians.
Assessment criteria:
• 3-5 years of experience in the Pharmaceutical or preferably Biotechnological Industry in the field of Quality Control, under GMP environment.
• Practical experience and technical proficiency in LC platforms (HPLC and UPLC with several detection methodologies, PDA, RI, Fluorescence, MALS/ELSD,…).
• Experience across other instrumental techniques (UV-Vis, IR, TOC, Mass spectrophotometry, DSC, AUC, Colorimetric assays, potentiometric assays, valorimetric assays…).
• Experience in managing and performing stability studies.
• Experience in the preparation of documentation (SOPs, Analytical Method Validation Protocols, Analytical Method Validation Reports,…).
• Proficiency at working within regulatory guidelines (EMA, FDA, ICH,…).
• Experience in analytical method transfer.
• Experience in analytical method validation according ICH guidelines.
• BSc in Pharmacy/Chemistry/Biochemistry and/or equivalent. MSc and/or PhD is desired.
• Proven working experience in GMP or GLP environments.
• High level of English.
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