Personal Information
Unternehmen/Arbeitsplatz
Hyderabad Area, India India
Beruf
Operational Manager at Novartis Healthcare Pvt. Ltd.
Branche
Medical / Health Care / Pharmaceuticals
Info
•A competent professional with around 12 years of rich experience in Quality Assurance and currently in Business Process Excellence / Strategy Development related role
•Demonstrated excellence in investigations for Customer Complaints, Deviations and Quality Events, CAPA management, Audit support during various Health Authority inspections and response to observations from such inspections.
•Responsible for leading internal audits, customer audits, managing audit findings, maintaining quality agreements and planning, conducting and documenting periodic cGMP audits of suppliers of raw materials, packaging materials, contract manufacturers and contract packagers.
•Excel in handling of chang...
Dokumente
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(7)Top 20 observation series # 7 21 CFR 211.42 (Subpart C-Buildings and Facilities – Design and construction features )
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US FDA Process Validation Stage 2 : No. Of Batches Required for Process Performance Qualification.
GMP EDUCATION : Not for Profit Organization
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Ensuring data integrity in pharmaceutical environment
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Data Integrity & Ethical Capacity Building
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Presentation on data integrity in Pharmaceutical Industry
Sathish Vemula
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Top 20 observation series # 5 21 CFR 211.100
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Pharmaceutical Capsules
jojohen
•
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Personal Information
Unternehmen/Arbeitsplatz
Hyderabad Area, India India
Beruf
Operational Manager at Novartis Healthcare Pvt. Ltd.
Branche
Medical / Health Care / Pharmaceuticals
Info
•A competent professional with around 12 years of rich experience in Quality Assurance and currently in Business Process Excellence / Strategy Development related role
•Demonstrated excellence in investigations for Customer Complaints, Deviations and Quality Events, CAPA management, Audit support during various Health Authority inspections and response to observations from such inspections.
•Responsible for leading internal audits, customer audits, managing audit findings, maintaining quality agreements and planning, conducting and documenting periodic cGMP audits of suppliers of raw materials, packaging materials, contract manufacturers and contract packagers.
•Excel in handling of chang...