Quality Assurance
I ensured that our manufacturing and quality control processes were in compliance with CGMP and GMP regulations, and I strictly followed FDA guidelines.
To minimize batch failures and production delays, I reviewed and approved batch records for accuracy, completeness, and regulatory standards.
Collaborated together with the teams in charge of manufacturing and quality control to make sure that batch records were finished on schedule and in accordance with legal requirements.
I closely monitored and controlled the encapsulation process to ensure the final dosage forms' integrity, quality, and uniformity.
I conducted inspections throughout the manufacturing process, both in-process and for final products, to verify adherence to specifications and promptly address any deviations.
In the formulation development process, I reviewed formulation protocols and made sure that all activities aligned with quality and regulatory standards.
I collaborated with cross-functional teams to address and resolve quality issues, including deviations, CAPAs (Corrective and Preventive Actions), and other compliance-related concerns.
Additionally, I supported routine internal audits to continuously improve our quality systems and maintain compliance with FDA and international guidelines.
I played a crucial role in the commercialization process by ensuring that all products met the necessary regulatory requirements for commercial release under FDA regulations.