- Conduct analytical testing, stability studies, and method validation for API samples using various instruments such as HPLC, GC, UV spectrophotometer, etc.
- Prepare protocols and SOPs related to QbD activities including Change Control Management.
- Ensure compliance with regulatory requirements by reviewing documents like BPR's, SOP's, Method Transfer Protocols, Method Transfer Report, etc.
- Collaborate with cross-functional teams to resolve issues related to documentation and review of documents.
- Maintain accurate records of all experiments performed in the lab.
Desired Candidate Profile
- MS/M.Sc(Science) degree in Chemistry or equivalent qualification.
- 4-8 years of experience in DQA team handling analytical methods development & validation.
- Robust knowledge of ELN (Electronic Lab Notebook) Review process.
- Experience with CDMO DQA operations is desirable.