- Management of a highly dynamic QA operations in a CDMO setup for manufacture of a range of products at various stages of clinical research as well as commercial stage.
- Host routine and new customer audits and agency inspections including pre approval and routine inspection for compliance assessment of manufacturing, storage and lab facilities.
- R&D and QA/QC of liquid oral drugs, topical, anti-infective and vaccines for challenging respiratory & sexually transmitted infections
- Proficient with OOS, CAPA investigations, GLP, GMP, GCP, ICH and FDA regulatory guidelines, and good knowledge of global regulations including WHO, EMA and ANVISA
- Efficient user of MS Word, PowerPoint, Excel, SharePoint, SAS, SPSS and GraphPad Prism, with excellent communication and organizational skills
- Proven learning agility, capacity to solve problems concisely, and ability to propose solutions with conviction, grounded in scientific data and quality regulations
PhD, CQE/CQA