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Job Location | Hyderabad |
Education | Not Mentioned |
Salary | Not Disclosed |
Industry | Pharma / Biotech |
Functional Area | General / Other Software |
EmploymentType | Full-time |
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. Review and preparation of master calibration schedule. Experience in conducting internal audits and audit preparedness. Implementation of good 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,
Keyskills :
internalaudit changecontrol ts glp control equipment validation deviations conducting calibration preparation documentation implementation COSO SAS70 alidationrep regulat yguidelines regulat Statut yAudit Exte