- Experience in conducting internal audits and audit preparedness
- Implementation of good documentation practices
- Knowledge of about Preparation of SOPs and guideline.
- Knowledge of about Change control management.
- Handling of incidents, Deviations,Out of specification and OOT.
- Exposure to regulatory audits.
- Experience in conducting internal audits and audit preparedness.
- Implementation of positive documentation practices.
- Knowledge about GLP and GMP.
- Knowledge about the qualification of equipment and instruments.
- Knowledge about regulatory guidelines and requirements.
- Knowledge about preparation and review of Development reports, validation reports and Dossier
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