Nitin Shendarkar
A dynamic experience in Corporate Quality Assurance, Regulatory Affairs, Project management, Operation management, Business Development, Contract manufacturing, 3P, P2P in Pharmaceutical & Medical device industry.
- Role
- Regulatory Affairs Specialist - Pmo at Tata Elxsi
- Location
- Thane, MH, IN
- LinkedIn followers
- 500 followers
About Nitin Shendarkar
Area of Expertise: 1) Project Management (Quality, Regulatory and Contract…
Experience
Regulatory Affairs Specialist - Pmo
Mar 2024 — Present
Responsible for Contract Organization / Third Party Project Management activities.o Plan and implement third party / contract organization projects.o Help define project scope, goals and deliverables.o Define tasks and required resources.o Collect and manage project team.o Allocate project resources.o Create a project schedule and timeline.o Support and direct team.o Lead quality assurance.o Report on the project status.o Present to stakeholders reports on progress as well as problems and solutions.o Implement and manage changes when necessary to meet project deliverables.o Evaluate and assess the result of the project.o Preparation & review of projects related documentsResponsible for Quality & Regulatory Management Projects and ensure its compliance as per regulatory guidelines.o Responsible for preparation of quality metrics, monthly report of customer activities.o Responsible for handling of Customer complaints.o Responsible for Quality technical agreement.o Responsible for Quality Oversight activities and perform site visits for assigned customers sites as on when required.o Weekly meeting with customers on open quality projects.o Responsible for conduct internal & external audit program.o Review of change controls, deviations & CAPAs along with its implementation of action plans.o Review of Product Quality Review (PQR’s) report of products.o Review audit compliance response, track CAPAs and ensure audit closure.o Review of documents required for dossier compilation & submission of finished products.o Perform gap assessment.o Review & approval of standard operating procedureso Review & approval of quality risk assessmento Review of validation documents.
Education
RGUHS, BANGALORE
Master of Pharmacy (M.Pharm.)
2008 — 2010
Skills
- Validation
- Pharmaceutics
- Hplc
- Pharmaceutical Industry
- Sop
- Fda
- Regulatory Affairs
- Cleaning Validation
- Glp
- 21 Cfr Part 11
- Capa
- V&V
- Change Control
- Technology Transfer
- Gmp
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.