Job highlights
Bachelors or Masters degree in Pharmacy is mandatory.
Job Summary
Review analytical methods for APIs and finished pharmaceutical products.
Responsibilities
Review analytical methods for APIs and finished pharmaceutical products.
Review analytical method validation protocols and validation study reports.
Review API and finished product specifications, limits, and acceptance criteria.
Review stability study data and shelf-life justifications in line with ICH guidelines.
Review DMF analytical sections and critical API quality attributes for compliance.
Verify analytical compliance for BE study sample testing and reporting activities.
Identify analytical documentation gaps impacting regulatory acceptability.
Support preparation of analytical-related responses to regulatory authority queries.
Verify alignment of analytical data with CTD Module 3 structure and expectations.
Maintain accuracy,
traceability, version control, and integrity of analytical records.
Requirements
Bachelor's or Master's degree in Pharmacy is mandatory.
Minimum three years of experience in QC or analytical validation roles.
Hands-on experience reviewing analytical method validation documentation.
Should have positive communication skills.
Robust analytical data interpretation and technical documentation review skills.
High technical ownership without laboratory or shop-floor operations.
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