Team Member- DQA

Roles and Responsibilities

• 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.
• Strong knowledge of ELN (Electronic Lab Notebook) Review process.
• Experience with CDMO DQA operations is desirable.