Responsible for review and execution of SOP, Master BMR and BPR,Qualification document and Validation Document.IPQA activities on Injectable,CAPA,QA SOP's,ensure the cGMP compliance,To review the audit trail report.Calibration Preventive maintenance
Responsible for review and execution of SOP, Master BMR and BPR,Qualification document and Validation Document.IPQA activities on Injectable,CAPA,QA SOP's,ensure the cGMP compliance,To review the audit trail report.Calibration Preventive maintenance
To prepare and review Validation Master Plan QMP, VMP, PVMP, Handling and storage of all quality document like BMR, investigation. CAPA and all other quality management, CAPA Monitoring of PPQ, requalification activities, OSD
Lead the preparation, review, and submission of new regulatory dossiers for Solid Oral Dosage Forms (SODF), Injectables, and/or Ophthalmic products to regulated markets. Lifecycle,Labelling Management, Stakeholder,Team Leadership,Process Improvement