Personal Information
Organization / Workplace
Hyderabad Area, India India
Occupation
Operational Manager at Novartis Healthcare Pvt. Ltd.
Industry
Medical / Health Care / Pharmaceuticals
About
•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...
Documents
(1)Likes
(7)Top 20 observation series # 7 21 CFR 211.42 (Subpart C-Buildings and Facilities – Design and construction features )
Sathish Vemula
•
8 years ago
US FDA Process Validation Stage 2 : No. Of Batches Required for Process Performance Qualification.
GMP EDUCATION : Not for Profit Organization
•
8 years ago
Ensuring data integrity in pharmaceutical environment
deepak mishra
•
9 years ago
Data Integrity & Ethical Capacity Building
GMP EDUCATION : Not for Profit Organization
•
10 years ago
Presentation on data integrity in Pharmaceutical Industry
Sathish Vemula
•
10 years ago
Top 20 observation series # 5 21 CFR 211.100
Sathish Vemula
•
9 years ago
Pharmaceutical Capsules
jojohen
•
11 years ago
Personal Information
Organization / Workplace
Hyderabad Area, India India
Occupation
Operational Manager at Novartis Healthcare Pvt. Ltd.
Industry
Medical / Health Care / Pharmaceuticals
About
•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...