Dattatraya Pawale
Manager Global Quality Audit and Compliance , Quality Assurance in Pharmaceuticals
- Role
- Manager -corporate Quality Compliance at SUN PHARMA
- Location
- Shrirampur, MH, IN
- LinkedIn followers
- 500 followers
About Dattatraya Pawale
1.Handling of Regulatory restrictions like Import Alert, Warning letters,483\'s,EU GMP non…
Experience
Manager -corporate Quality Compliance
Dec 2013 — Present · Mumbai, IN
Vendor Audit\'s of Pharmaceuticals API vendors/KSM /Packaging material,Medical device\'s vendors etc.(Surveillance,For case,due diligence)Handling of Regulatory restrictions,Warning letters,FDA 483\'s and its impact assessment at own sites.Complaint handling and CAPA management Risk assessment and Gap assessment and compliance.Quality agreement assessment and ensure business continuity.Risk assessment of API, Excipients,Packaging material vendors.
Education
Pune University
Master's degree, Chemistry
Skills
- Gmp
- Quality Auditing
- Validation
- Quality System
- Sop
- Fda
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