Lab experience for Analytical Method Development, regular and stability sample analysis. Handling of HPLC for Assay, Dissolution, Related substances tests for solid orals.
Knowledge and experience in the international regulatory environment of clinical trial applications, non-clinical and/or clinical variations to marketing authorizations and product labelling relevant for biotechnology and/or oncology products
Exposure to OSD Manufacturing operations like Compression, Pellet coating, Capsule filling, Primary Packing & Secondary Packing. Expertise in e-BPR and e-log will be added advantage.