Responsibilities:
1. Batch Record Review
Batch record review2. Release Preparation
Support the release preparation activities, in order to generate a complete batch dossier package3. Deviation Management
Review, assess, and close minor deviations. - Perform basic Root Cause Analysis (RCA). - Escalate major and critical deviations to senior QA or management.4. CAPA Execution & Follow-Up
Initiate and execute CAPAs. - Track and ensure timely completion of CAPA actions. - Verify CAPA effectiveness and document findings.5. Quality Investigations & Compliance
Support investigations for minor product complaints and minor process deviations and events. - Ensure proper documentation and compliance with GMP regulations.6. Change Control Support
Support minor Change Controls related to deviations and CAPAs. - Ensure proper documentation of Change Control impact.7. Audit & Inspection Support
P...