Contact
Vaibhav Misra
www.linkedin.com/in/vaibhavm01 Associate Director - Professional Services (Leadership, GxP
(LinkedIn) Implementations, IT Roadmap, CSV, DI/ ALCOA+, QMS, Audits,
Change Management, 21 CFR Part 11)
Top Skills Noida
Project Management
Requirements Analysis Summary
SDLC

Primary Skills - Leadership, System Implementations, Initiatives,

Languages IT Roadmap, Program Management, Leadership, IT
English Implementations, Procedural/Process Evolvement, Pharma IT
Business Analysis,
Certifications GxP Systems Release & Implementations, IT Quality, Hosting and
GMP: Auditing Conducting IT Audits, Computerized System Validation (CSV)
GMP: Data Integrity and Computer GxP Systems Change Management, Risk Assessment, GxP
System Validation
Change Management, Team Management, Vendor Management, IT
Budgeting - CapEx/capital and OPEX, License Management.

Oracle, PL/SQL, Database Development, Solution designing,

performing POCs to support the design approach etc.

Computer Science, ARGUS Drug Safety, PV Consulting, TrackWise

Usage for CCRs, UPDs, PDs, Investigations & CAPA, Database
Migration using PL/SQL, ETL, Code Reviews, Team mentoring,
Team/Tech leadership, CSV, SDLC, Client interaction, Reviewing
documents (URS, FRS, CS, CMD, PVP, VSR, QP/TP, Design etc)

Secondary Skills - OQ, PQ, D2K (Oracle Forms & Reports), XML,
HP Quality Center/ ALM, Creating, maintaining and tracking work
breakdown for the team, Version Controlling tools, SQL Developer,
PL/SQL developer, Toad, Performance Tuning, Drug safety techno-
functional consultancy

Experience
RxLogix
4 years 2 months

Associate Director - Professional Services

August 2018 - Present (2 years 5 months)
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Noida Area, India

Leading the implementations and validation of GxP systems

Senior Manager
November 2016 - July 2018 (1 year 9 months)
Noida Area, India

Web: www.RxLogix.com

Heading the GxP Releases, IT quality and CSV effort for the India ODC. My
role includes:
 
1. Leadership : Team management in a global environment - primarily India
& US, Building the team from scratch, Resource engagements, Resource
capacity planning, Resource gap identification and recruitment, Performance
monitoring, Mentoring, Performance reviews and appraisals.

2. IT Delivery : Managing and governing implementation and validation

programs of GxP systems. Ensuring timely and compliant deliveries/ releases
for top-10 pharma companies.

3. CSV : Established the GxP practice and built the team, GxP system
releases, SDLC, 21 CFR Part 11 Compliance, Data Integrity, ALCOA+,
Ensuring SOP compliance, Managing and supervising quality for six PV
products and tools, guiding the quality and the project team on CSV needs,
reviewing and approving CSV deliverable for all releases. Product Quality
Management and Implementations.

4. Corporate Quality : Setup the IT QMS/ SOPs skeleton from scratch, Hosting
external audits, Reviewing/ approving the SOPs/WIs/Templates, QMS/SOPs
Remediation, Leading internal audits, Internal audit planning, Audit responses

SUN PHARMA
Project Manager - R&D IT (Erstwhile Ranbaxy Laboratories)
July 2014 - November 2016 (2 years 5 months)
Gurgaon, India

Web: http://www.sunpharma.com

IT Program Management, Business Analyst, Pharmacovigilance/Drug Safety

SME and Techno Functional consultant(Argus Safety) , IT Service Delivery,
CSV / Validation Consulting, Experience on IT audits, IT annual budgeting -

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CAPEX/OPEX, Vendor Assessment, Selection and Management, Stakeholder

Management, System/Software Assessment, Comparison and Implementation,
IT Roadmap, Monitoring Data Backup diligence and performance of the
Disaster Recovery (DR) drills.

Interfacing R&D Departments:

Clinical Pharmacology & Pharmacokinetics
Clinical Pharmacology Unit
Pharmacovigilance/Drug Safety
Product & Packaging Development
Drug Formulation
Plant/PTT

Project 1: Argus Safety System - Phamacovigilance Techno functional expert/

Business Analyst

Project 2: New deployment- Pharmaceutical inventory and column

management system Project Management, Requirement Gathering, Analysis
& Finalization, People Management, Vendor Survey & Management,
Computer System Validation CSV, SDLC Finalizing the solution to serve the
business need, vendor negotiation, Business Analyst

Project 3: Support & Maintenance- Artwork Management System Oracle Agile

PLM 7.1.x - Project Management/Team Management, CSV

Foresight Group International, AG

PV Consultant - Argus Drug Safety
May 2013 - June 2014 (1 year 2 months)
Noida

Senior Consultant - Database Technologies / Pharmacovigilance

Web: http://www.foresightgroup.com/

Project 1:
Integration Of Customized E2B Action For Inbound Follow-Ups

Client : Top- 5 Pharma Co.

Domain : Pharmaco-vigilance / Drug Safety / Life Sciences
Organization : Foresight Group

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Synopsis : Integrating the customized logic to Oracle Argus Drug Safety Suite
as per the business requirement.
Solution designed for high configurability
Requirement gathering
Requirement analysis
Preparing Proof of Concept (POC)
Deciding the timelines and the project plan
Development & preparing unit test cases.
Client interaction.
Computer System Validation CSV

Project 2:
Data Migration

Client : Top -5 Pharma Co.

Domain : Pharmaco-vigilance / Drug Safety / Life Sciences
Organization : Foresight Group

Synopsis : Migrate the case related information from Perceive Drug Safety
systems into Argus Drug safety system.
Scope of the project includes migration of all case related data from their
Japanese system Perceive to Argus drug safety system. It also includes
merging of the client’s global cases that were already there in Argus 7.0.1.
The key activities involved in the project are analysis of source and target
systems, mapping of data elements from source to target, development of
migration scripts, testing and validating migrated data.

Dell
Senior Technology Analyst - Application Development
November 2010 - May 2013 (2 years 7 months)

Dainik Jagran
Sr. Software Engineer
July 2006 - July 2010 (4 years 1 month)
Worked on Oracle, PL/SQL & D2K (Oracle Forms & Reports)
ETL/ Data Migration from distributed to centralized system.
Support and maintenance of the ERP.

NIIT Technologies Limited

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Software Engineer
2010 - 2010 (less than a year)
Enhancement of a legacy product (Airlines/ Travel domain)
Worked on PL/SQL and D2K.

Education
University Institute of Engineering and Technology
Bachelor of Technology (B.Tech.), Computer Science

Sheiling House School

ISC 

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