~HIGH IMPACT SENIOR VALIDATION EXECUTIVE & BUSINESS OPTIMIZATION,
SIX SIGMA GREEN BELT CERTIFIED IT PROFESSIONAL~
Seeking Challenging roles as a Project Manager and Validation Head, Senior Auditor & Regulatory compliance Officer
Extensive Business background with sound understanding of the Program Management, Project Management, FMEA,Computer system Validation Design and Delivery.
Computer System Validation (GxP), and part 11 compliance,
Cloud computing (SaaS) validation
ERP & SAP validation, LIMS system ( Labware) and Compliance Management,
Quality Management Systems,
IT security system(ISMS) ISO 27001: 2009,
Pharma IT Solution Development,
Business Analysis, Project Management, Pharmaceutical Manufacturing, Validation of Process and Facility.
Pre Sales Support.
Repeatedly produced sustained business and revenue growth in changing markets
A seasoned professional with over 13 years of experience in:
Computer System Validation (V&V)
Process & Facility Validation
IT Systems Development
Data Migration validation
RAVE & InForm Integration Validation
System Integration Validation
21 CFR Part 11 compliance
Operation & Administration
Customer complaint handling
Oracle OUM L2 and Six Sigma Certified with experience in all Computer system Validation and Quality system management, of implementing global Validation and IT projects management and business solutions for mastering customer’s business requirements in Life sciences & Healthcare industry. Currently working with ORACLE Corporation as a Consulting Technical Manager- Validation.
Designing, Deploying and Executing the Validation solution for Hosted as well as on Premise Life sciences, Clinical and Health care implementations.
Traveled to international destinations like USA (Entire East cost & West coast), Japan (Tokyo & Osaka), UK (London & Berlin), Netherlands, Australia, Dubai, Singapore, Russia, China & Bangladesh.
Well versed in creating and reviewing Validation & Technical Proposals, Define and estimate Scope, Process Needs Assessment & Solutions, Business Requirement Documents, Data Migration & Project Plan, Services Agreement, information specifications, and project objectives. Possess strong oral, written and organization skills, excellent time management skills and a strong ability to prioritize tasks. Self-motivated and industrious professional with good technical, communication and leadership skills.
Expertise in Validation Service Delivery, Risk management and Compliance, Projects management Services, Administration, Testing, Consulting, Planning, Documentation, Installing, Implementing, Troubleshooting, Quality Process Management & Maintenance.
Proficient in providing technical support, perform trouble-shooting functions and resolve customer issues.
Ability to handle systems management, test environment management, Validation Phases management (IQ, OQ,DMQ, PQ, UAT & OPQ ) and testing across multiple life sciences applications and operational scale.
Proficient in Validation of Cloud hosted applications and cross applications integration delivery.
Excellent knowledge of Computer system validation GxP, GAMP 5, 21 CFR Part 11, Data Migration validation, Equipment Validation, Facility Validation, Cleaning, HVAC & Water Validation etc.
Proficient in Risk Management & Regulatory compliance audits. Cloud computing (SaaS) validation, ERP & SAP validation etc.
Expertise in Regulatory Standards like GxP, 21 CFR Part 11, 21 CFR Part 210, 211, cGMP, HIPPA, Good Documentation Practice, Good Automated Manufacturing Practice – GAMP 5 and ISO
Proficient in Compliance Management, Quality Management Systems, IT security system(ISMS) ISO 27001: 2009, Pharma IT Solution Development, Business Analysis, Project Management, Pharmaceutical Manufacturing, Validation of Process and Facility and Pre Sales Support.
Functional knowledge into Argus, InForm, Clear Trial, CTMS, LabPas, Sebial CTMS, CDA
Top contributor Award for HSGBU for FY2014Q3
Awarded as “Knowledge Champion” in HCL for the year 2007-2008.
Bench Marked the Validation Process and Procedures in Baxter India.
Awarded as “Excellent Performer” for the improvement of the product in Promed Exports.
Since Jan’09 Oracle Corporation, N0ida
Consulting Technical Manager (Validation)
Manage Team of 10 Sr. Principal consultants & Principal consultants for the Validation
Manage execution of cross-functional plans and track progress of activities
Integrated resource and budget planning
Identify gaps, potential bottlenecks or delays, and challenge assumptions
Risk management incl. critical path, risk assessment, scenario creation and analysis
Proposes options to close gaps and get projects back on schedule
Compile and communicate project reports
Facilitates and contributes to strategy and planning meetings
Guide team processes, ensuring consistency, transparency and optimization
Implement / pull in best practices to project teams; foster continuous improvement by ensuring knowledge, experience exchange
Manages third party vendor relationships and collaborations
Lead and drive the team to achieve the required business standards in terms of deliverables, quality, safety, and KPI’s.
Manage all validation related activities, including validation strategy and approval of validation master plans, protocols, deviations and reports.
Handling Go-to person for day-to-day client communications
Owning problem-solving leadership and guide multiple project teams
Understanding clients specific processes and the business requirements;
Assisting client during the Implementation, integration and user acceptance testing phase of the project;
Preparing for system cutover strategy and creating a cutover plan; and provide support during the go-live phase of the project.
To lead continuous improvement initiatives for the group.
On Cloud (SaaS) global implementation for Japanese and global client:
oSanten Pharmaceuticals (Japan)
oChaui Pharmaceuticals (Japan)
oOtsuka Pharmaceuticals ( US, UK,Germany & Japan)
oReckitt Benckiser (United states)
oBoston BioMedical(United states)
oBellerophon (United states)
On Premise implementation of :
oOtsuka Pharmaceutical (United states)
oBoston Scientific (United states)
oAmgen Pharmaceuticals (United states)
Owned and delivered complete end to end Validation solution for Data Migration from Perceive to Argus.
Developed reusable asset of Valpack.
Project Management Accredited from Oracle Global Business Units consulting
Top contributor Award for HSGBU for FY2014Q3
Validation of solution designed for Integrating InForm and Argus and performance testing of Argus for Novo Nordisk.
Development of End to End validation for SaaS (Software as a service) for Argus on Demand.
Validation of Reporting rule configuration for USFDA & EMEA – Astellas
Validation Consultancy for Hot fixes and Business configuration for Genzyme(Cambridge, MA)
Validation Consultancy for E2B Transmit & Import for IBM-Chugai;US
Data migration Validation & Data up gradation from 4.1 to 5.0.1 for Lilly project
Business configuration for Amgen
Argus Implementation for Boston Scientific
Sep’07 to De’08 HCL Technologies Limited, Noida
Sr. Business Analyst
Mar’07 to Sep’07 Baxter India Limited, Manesar
Team Lead – Validation & QA
Apr’05 to Feb’07 Pharma Plan India Limited, New Delhi
Project Assistant – Validation & Compliance
Feb’02 to Feb’05 Promed Exports Pvt Limited, New Delhi
Senior Executive - QA
Apr’01 to Feb’02 Welcure Drugs & Pharmaceuticals Ltd, Bhiwadi
Chemist – QA/QC
2000 B-Pharma from Dr. K.N.M.I.P.E.R., C.C.S University of Meerut with 68%
Six Sigma Green Belt Certification
Oracle University – OUM Certified
Post Graduate Diploma in Pharmacovigilance – Cliniminds
DBA (Secured Grade B) - IGNOU
L2 certified from Oracle Project Management Accreditation GBUCboard
Organization: HCL Technologies Limited
Designation: Sr.Business Analysts
Team Size: 15(internal)
Role: Head-Subscriber Management System/GM/IT-Head/CIO/Delivery Head
Worked as SR. Business Analyst in Global Life Science and Healthcare division of HCL Technologies Limited, Noida
Validation & Compliance Specialist for Verification & Validation of Baxter Logix Solution
Business Analyst for SAP Comprehensive Clinical Trial Solution
Business Analyst for ePedigree & eSubmission Solution
Organization: Baxter India Limited
Designation: Team Lead – Validation & QA
Description: Baxter India is one of the leading manufacturers of SVP & LVP Dialysis Products.
Team Size: 20
Role: Team Lead – Validation & QA
As an Team Lead – Validation & QA, handled
• Computer System Validation Documents.
• Standard Operating Procedures.
• Facility Validation.
• Review and Approval of Change Control of Equipment and Process.
• Qualification of Equipments – DQ, IQ, OQ & PQ.
• Internal GxP audit.
• FDA audit preparation and review.
• Conducting GMP Training.
Organization: Pharma Plan India Limited
Designation: Project Assistant – Validation & Compliance
Description: Pharma Plan is one of the world’s leading pharma engineering companies and service partners for the pharmaceutical industry. The company supplies customer-oriented qualified solutions characterized by GMP competence. It is one of its kinds in the field of pharma consultancy, which is basically a part of German organization working in India.
As a Project Assistant – Validation & Compliance, handled
• Preparation & Execution of Validation Protocols
• Verification of Process and Instrumentation Diagrams
• Gap Analysis & Risk Assessment
• Project Planning and Managing the team
• Conducting GMP & GxP Audits
• Preparation of Change Control Documents
• Qualification of Equipments – DQ, IQ, OQ & PQ
• FDA audit preparation and review
• Conducting GMP & GxP Training to the client teams
• Preparing Marketing Presentations and worked in Proposals to Clients
Organization: Promed Exports Pvt Limited, New Delhi
Designation: Senior Executive - QA
Team Size: 12
Promed Exports is a pharmaceutical export company, which is in to 100% export of the formulations into Russia, CIS, Myanmar, and Philippines, is planning for South Africa. The company is engaged in to manufacturing of Tablets, Capsules, Liquid oral, Dry Syrup etc & has a turn over of around 7.1 million USD
Organization: Welcure Drugs & Pharmaceutical Limited, Rajasthan
Designation: Chemist – QA/QC
Welcure Drugs & Pharmaceuticals is one of the leading manufacturers of various generics OSD.
As an Chemist, I have been trained & worked in
• Preparation of Site Master File
• ISO related documents & Standard Operating Procedures
• Drafting the quality documents & Analysis of raw materials, intermediates, and finished products
• Conducting quality audits and facility audits