Sr. Executive / Executive - Quality Assurance

Key Responsibilities

* Managed Quality Assurance activities for API and Intermediate manufacturing in compliance with GMP and regulatory requirements.
* Led investigations of deviations, OOS/OOT results, quality complaints, CAPA, and change control to ensure product quality and compliance.
* Reviewed batch manufacturing records, laboratory records, specifications, SOPs, validation/qualification protocols, and quality-related documentation prior to batch release.
* Performed batch release of APIs/Intermediates and supported Product Quality Review (PQR), Quality Risk Assessment (QRA), and stability program activities.
* Coordinated internal audits (self-inspections), GMP training programs, and ensured training compliance across departments.
* Oversaw equipment qualification (DQ, IQ, OQ, PQ), validation lifecycle, and documentation including Quality Manual, Site Master File, and Validation Master Plan.
* Ensured analytical methods and quality control specifications complied with current pharmacopoeia standards and customer requirements while monitoring contract manufacturers.
* Issued quality alerts, managed quality documentation, and collaborated with cross-functional teams to drive continuous quality improvement and regulatory compliance.