Milind Kulkarni
External Manufacturing Quality Senior Lead - General Manager EM Quality, Branded Generics, India Export region at GlaxoSmithKline India Global Services Pvt Ltd
- Role
- External Manufacturing Quality Lead - General Manager Em Quality, India Export Region at GSK
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Milind Kulkarni
Highly experienced Quality Professional with over 31 years of proven track record and…
Experience
External Manufacturing Quality Lead - General Manager Em Quality, India Export Region
Jan 2017 — Present · Mumbai, IN
Leading External Supply Quality for GlaxoSmithKline Asia Pvt Ltd, India Export Region, managing Quality oversight of CMOs exporting Branded Generics to regulated markets. Additionally playing NPI Quality Lead role for New Product lanuch project involving multiple markets across APAC region.
Education
Mumbai University Mumbai
B.Sc.
1988 — 1990
Mumbai University Mumbai
M.Sc.
1991 — 1993
Skills
- Change Control
- Quality Auditing
- Aseptic Processing
- Pharmaceutics
- Glp
- Trackwise
- U.s. Food and Drug Administration (Fda)
- Capa
- Quality System
- V&V
- Compliance
- Cleaning Validation
- Quality Control
- Regulatory Submissions
- Gmp
- Regulatory Requirements
- Validation
- Dissolution
- Computer System Validation
- Anda
- Regulatory Affairs
- Quality Management
- Lims
- 21 Cfr Part 11
- Standard Operating Procedure (Sop)
- Corrective and Preventive Action (Capa)
- Pharmaceutical Industry
- Sop
- Deviation Management
- Fda
- Technology Transfer
- Quality Assurance
- Hplc
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