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