R&D Quality Assurance Professional

Responsibilities :

Verification and Validation :

• Lead the verification and validation of analytical and microbiological methods, ensuring they meet all regulatory and internal quality requirements.
• Design, execute, and document method validation protocols, including accuracy, precision, specificity, and robustness studies, in compliance with FDA, TGA, ICH, and EMA guidelines.
• Review and approve validation protocols and reports, ensuring they are scientifically sound and fully compliant with Good Laboratory Practice (GLP) and other relevant regulatory standards.

Analytical and Microbiology Methods :

Data Review and Integrity :

Regulatory Compliance :

Continuous Improvement :

Training and Development :

What youd gain :

Qualifications :

Skills Required

analytical method validation , Sterility Testing