Dipak Phalak
Manager CQA | QMS, Vendor management, Injectable & Solid orals (Small molecules & Biological formulations reviewer)
- Role
- Manger-cqa i Cipla Ltd at Cipla
- Location
- Navi Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Dipak Phalak
Start with quality, destination will be excellence. Keeping the approach in mind…
Experience
Manger-cqa i Cipla Ltd
Jul 2024 — Present · Mumbai, IN
Handling of in-house & third-party projects with QA prospective.>Quality review of documents generated during product development to launch.>Supports regulatory response review along with dossier sections of drug product.>Internal and external audit.>Handling of change control, deviations, investigations & CAPA.>Digital Tools & Platforms: Trackwise, ELN, Opentext Documentum D2, Leucine.
Education
Rajiv Gandhi University of Health Sciences (RGUHS)
Master's degree
2008 — 2010
GCOP, Amravati.
Bachelor of Pharmacy - BPharm
Skills
- Cleaning Validation
- Ectd
- Pharmacovigilance
- Gmp
- Generic Programming
- Formulation
- Pharmaceutical Research
- Validation
- Dissolution
- Regulatory Submissions
- Pharmaceutics
- Pharmaceutical Industry
- Sop
- Fda
- Regulatory Affairs
- Glp
- Drug Delivery
- Regulatory Requirements
- Hplc
- V&V
- Anda
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