Key Responsibilities
* Support continuous improvement initiatives to strengthen the Quality Management System
* Represent QA in cross-functional teams, liaising with manufacturing, QC, support functions, and engineering for process transfers
* Review, assess, and approve quality records such as deviations, change controls, CAPAs, investigations, and effectiveness checks
* Author, review, and approve GMP-related documents and SOPs to ensure compliance
* Present Drug Product QA topics during customer audits and regulatory inspections
* Participate in internal audits as needed and organize monthly Quality Council meetings
* Track and report key quality indicators and maintain the KPI dashboards
* Conduct gap assessments for audits and inspections at other facilities
* Support daily HOSHIN Tier 1 and Tier 2 updates and act as back-up for QA leadership in HOSHIN processes
* Act as primary contact for QA questions related to manufacturing operations and project-specific risk assessments
* Review and approve process documentation, batch records, and transfer documents
* Support batch release activities, including reviewing executive batch records and making disposition recommendations
* Manage customer interactions concerning deviations, complaints, and deviations from quality standards
* Act as delegate for batch disposition and conditional release decisions