Are you passionate about technology and like to take on complex technical challenges? Do you want to work in exciting projects at renowned clients? At ALTEN we believe that knowing and meeting the expectations of our consultants is a key factor in our success. Our consultants make the difference. Do you want to make the difference too?
▪ Analytical life cycle management
▪ In collaboration with the Analytical Steward and QC teams, evaluate the performance of the analytical method in collaboration with the Analytical Steward and QC sterile team
▪ Manage the Internal limit process and support MS&T with the OPV process
▪ Manage validation and transfer of analytical methods
▪ Create / Update testing Monographs and associated documents (VPP, OS, IS)
▪ In collaboration with the AS&T team, he/she propose/lead analytical or process improvement
▪ Is change phase manager for changes linked to analytics
▪ Is responsible for managing the Pharmacopeia evaluation process
▪ Independent manage stability studies from design to reporting
▪ Manage and handle stability sample to ensure compliance with standards
▪ Manage sample Distribution locally and externally
▪ Manage the Follow up stability program
▪ Lead or support investigation on deviation or OOS/OOT/OOE
▪ Support other functions on a case by case basis on the topic for which he is responsible
▪ Is responsible to timely provide the APQR sections that are assigned to him/her
▪ Is responsible for the timely completion of the pharmacopeia update assigned to him/her
▪ Is responsible for the format compliance in the documentation management system (e.g.: Subway)
▪ Technical education & 5 years relevant experiences or Master in Science (Chemistry, Biotech, Biology, Pharmacy,...) + 3 years working or PhD in the same fields with 1 year experience.
▪ English: Fluent
▪ Experience in instrumental analytics (HPLC, UV, etc.) preferably in pharmaceutical quality control, quality assurance or pharmaceutical production. Adequate knowledge of Microsoft applications as well as SAP, Chromeleon, etc
We are looking forward to getting to know you and your ambitions!