Primary Objective / Purpose
To execute rigorous analytical testing to guarantee vaccine quality, safety, and efficacy during validation and commercial production.
Key Responsibilities
• Execute in-process testing, raw material testing, and stability testing.
• Perform batch release testing for PPQ batches.
• Conduct analytical method validation and equipment qualification.
• Oversee environmental monitoring programs.
• Ensure strict analytical data integrity during laboratory operations.
Key Deliverables
• Test results and Certificates of Analysis (COA)
• Analytical method validation reports
• Stability & Environmental monitoring reports
Required Skills & Qualifications
• Degree in Chemistry, Microbiology, or related science.
• Hands-on experience with analytical instrumentation.
• Deep understanding of Good Laboratory Practices (GLP).
• Experience with LIMS (Laboratory Information Mgmt Systems).