Consulting validation manager

~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:

Regulatory

Compliance Audit

Computer System Validation (V&V)

Process & Facility Validation

IT Systems Development

Equipment Qualification

Data Migration validation

RAVE & InForm Integration Validation

Business Analysis

Training

Designing &Implementation

System Integration Validation

21 CFR Part 11 compliance

Financial Planning

Program Management

Operation & Administration

People Management

Process Enhancement

Outsourcing

Vendor Management

Customer complaint handling

CAPA

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.

PROFILE SNAPHOT

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.

CORE COMETENCIES

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

ACHIEVEMENTS

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.

WORK EXPERIENCE

Since Jan’09 Oracle Corporation, N0ida

Consulting Technical Manager (Validation)

Responsibilities:

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.

Conduct training.

To lead continuous improvement initiatives for the group.

Highlights:

On Cloud (SaaS) global implementation for Japanese and global client:

oSanten Pharmaceuticals (Japan)

oChaui Pharmaceuticals (Japan)

oKowa 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

ACADEMIC QUALIFICATIONS

2000 B-Pharma from Dr. K.N.M.I.P.E.R., C.C.S University of Meerut with 68%

Certifications:

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

PROFESSIONAL DETAILS

Organization: HCL Technologies Limited

Designation: Sr.Business Analysts

Team Size: 15(internal)

Role: Head-Subscriber Management System/GM/IT-Head/CIO/Delivery Head

Responsibilities:

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

Responsibilities:

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.

Responsibilities:

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

Responsibilities:

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

Contact this candidate