Sadia A. Alam Email and Phone Number

Efficiently format diverse client medical assessment reports by maintaining consistency and confidentiality as per clinic guidelines.

• Performed GMP and Validation activities within the sites.• Executed Process Validation and Packaging (primary and Secondary) Validation activities including Protocol ad report writing.• Planning and execution of Prospective, Retrospective, and Concurrent Validation of drug materials, manufacturing equipment, facilities and utilities.• Collaborated with cross functional teams and ensured validation is compliant with cGMP, ICH, ISO and Internal standards. • Delivery of assigned… Show more • Performed GMP and Validation activities within the sites.• Executed Process Validation and Packaging (primary and Secondary) Validation activities including Protocol ad report writing.• Planning and execution of Prospective, Retrospective, and Concurrent Validation of drug materials, manufacturing equipment, facilities and utilities.• Collaborated with cross functional teams and ensured validation is compliant with cGMP, ICH, ISO and Internal standards. • Delivery of assigned projects as per the Validation Master Plan.• Support and creation of Change Controls, CAPAs, Deviations within the Track wise Quality Management System (QMS).• Performing root cause analysis and investigations.• Presentation of validation data to internal and external Auditors as lead or support (when requested).• Prepare the annual product review reports of the products manufactured at plant.• Data collation, interpretation, review for trend analysis and Annual Product Review Report (APRR) writing.• Creation of Stability protocols and management of stability samples. Show less