� Worked on requirements analysis, gap analysis, pain points of legacy systems

used, analysing existing product and customization required.

� Expertise in understanding and documenting business requirements and
converting them into technical specifications.

Currently working in the BFS vertical of Cognizant Business Consulting(CBC) as a

consulting analyst.

Have been working on RFPs and simultaneously doing research on various solutions
(technologies/ applications).
These solutions when provided to the client will improve their efficiency as well
as profits.

Good knowledge of digital marketing/payments/ retail banking in the bfs domain.

Have a short but in depth exposure to FMCG industry. Worked at Britannia Industries
for three months where I extensively worked with the marketing, sales &
distribution team for Good day Chunkies. Good understanding of the retail sector
and the retail value chain.Performed Focus Group discussion/ market research in 5
important cities.

Good exposure to client engagement, requirement gathering, providing best solutions

to clients, business development technical sales

A/QC) Specialist
Company NamePharma Consultant - CQV,QMS,GMP,GLP / Independant
Dates EmployedDec 2014 � Present Employment Duration3 yrs 3 mos
LocationAsia
To introduce myself with professional background in brief:

Having been significantly contributing over 20 years of experience in the following

areas of Quality Management,Commissioning,Qualification & Validation, Regulatory
and Process Systems for major Pharma, Life Science, Vaccine production, API and
other GMP consultancy companies in India and abroad:

Project Management:
? Design and Development Reviews(Facility thru Operations)
? Planning and Procurement Plan (Equipment thru Materials)
Validation Management:
? Commissioning, Qualification and Validation (Design thru Operation)
? Validation Life cycle documentation (Procurement thru Retirement)
? All types of Pharmaceutical Validations
Quality Management:
? GAP Analysis and Risk Assessment (Facility thru Process)
? Implementation of effective cGXP/QMS & its documentation
? High level documentation (Policy thru Maintenance)
? Training (Basic thru Technical)
? Third party Vendor Audits & certification
? Technology Transfer Assistance & Documentation
? Facility compliance Audits
? Investigations (Project thru Production)
Automation Management:
? Automation Control Systems (Design thru Operations)
? Software Management System (Planning thru Testing)
? Validation Life cycle Management
Regulatory Management:
? Assistance in Regulatory filing (DMF, eCTD etc.)
? Facility readiness for Regulatory Audits
? Regulatory Audit Response (National & International)

I had significantly contributed my skills and expertise with Cadila, Indian

Immunologicals, Aurobindo, Akums Pharma, Semler(for South Africa),Biological E.Ltd,
Syngene Intl Ltd ,Reliance Life Sciences, Dr.Reddy's Lab, and Cipla Ltd.

Ethical Responsibility :
a). Establishment of human friendly old-age homes, Food supply canteens, Economic
Health Care centers, Spiritual Meditation centers in near future as part of socio-
economic development of co-humans through Mother Seva Foundation

Opportunities are always open for every talented..in this BIG world..Good Luck!!

Experienced Quality Assurance Manager with a demonstrated history of working in the

pharmaceuticals industry. Strong quality assurance professional skilled in U.S.
Food and Drug Administration (FDA), Quality Control, Verification and Validation
(V&V), Good Laboratory Practice (GLP), and Corrective and Preventive Action (CAPA).

1) 9+ years of expertise in delivering Testing & Validation assignments for Life

Sciences customers
2) Expertise in providing Validation solution for COTs products and IT
applications/programs ( e.g. Argus, LIMS, Oracle LSH, Veeva InGenius (Sales Force
App), Document Management System (FirstDoc), Test Management & eSignature tools
etc.)
3)Well acquainted with FDA/global regulations for GxP, Computer System Validation
(CSV) and Medical Devices
4) Experienced in Validation Planning, Configuration specifications, Service
Catalog, GxP Roles and Responsibilities, Functional Risk Assessment and Risk
Management Plan.
5) Proven track record in Delivery, Quality process, Operational, Innovation, team
management and business development excellence
6) Expertise in developing Validation Protocols for Installation Qualification
(IQ), Operational Qualification (OQ), Performance Qualification (PQ), executing
Validation protocols and Report execution results
7) Experienced in setting up Quality Management System (QMS) for Pharma customers
(i.e. defining SOPs, Working Practices and Templates)
8) Worked with Life Sciences clients like Merck, Abbott, AstraZeneca and Otsuka
from offshore as well as onsite

� Establishing & maintain key validation deliverables throughout the system

lifecycle, including user/ business requirements gathering & aligning it with
relevant business processes and user acceptance test planning.

� Perform risk assessment in collaboration with development and testing team to

identify, categorize, mitigate & follow through until remediation is complete.

� Working with and provide consultancy to development and testing teams to ensure
the accuracy and consistency of system development deliverables. Reporting results
and reviewing anomalies, as appropriate, to the Manager, validation & business
owner.

� Authoring, approving, executing & maintaining Validation documentation for

developed, managed, and/or purchased systems.

� Accountable for the continued maintenance of validated systems post go-live.

� Perform continuous reviews and evaluations of regulatory standards and guidance

documents. Reporting, analysis, and training on how such standards impact and
affect organization.

� Supporting the establishment and implementation of change control

processes/requests relating to system development and Validation.

� Oversee technology quality and validation related CAPA management & facilitate
effective corrective and preventive action implementation.

� As an Audit & inspection representative, represent technology quality measures

and controls including CSV (Computer System Validation) in sponsor audits &
regulatory inspections. Support in the collation and answering of Request for
Information (RFI) questionnaires and other appropriate sponsor requested
information.

� Facilitates the identification and development of Standard Operating Procedures

related to Computer system validation (Development & testing).

� Providing training and guidance to development and testing team regarding

compliance and interpretation of SOPs & Requirements.

My responsibilities include review and sign-off of Work units, Requirements, Test

Cases, SDLC documents/Deliverables across life cycle of a release
1. Review of Work Units at Test and Build Phase
2. Review of User requirements(UR) and Functional specifications(FS)
3. Review and consulting of Test Cases before execution post NVT(Non validation
Testing)
4. Review and consulting of Test Cases post execution VT(Validation Testing)

5. Review of RFC(Request For Change) at Implement and Closure stages for Pre
Implementation Plan, Post Implementation Review, Migration Details, Work unit
tasks, Code review document, Compliance Analysis, Compliance Plan, Test protocol,
RTM(Requirement Traceability Matrix), Test Plan, etc

Requirement Gathering, Conducting Client Workshops, working in an Agile

environment, writing User Stories, involved in Prioritisation with the
stakeholders, Acceptance Testing, Manual Testing, creating Release Plans and
performing Showcases to Clients for feedback and acceptance.

� Understand the business issues and data challenges of client's organization

and industry
� Identify client organization's strengths and weaknesses and suggests for
improvement
� Review requirements, business processes and recommendations of proposed
solution
� Develop functional specifications and system design specifications for client
engagements
� Training Users on Product Functionality
� Interact with Clients; prepare a roadmap for Implementation of Software
� Issue analysis and escalation as per the process defines
� Functional testing of software to provide bug free software to clients
� Responsible for gathering and analyzing Business requirements of the project
� Transmitting client requirements to development team
� Closely work with project management and development team to ensure on-time
delivery
� To suggest development team during product development to meet clients
business needs
� Responsible for helping the development team to understand the functional
requirements
� Prepare Precise and detailed Requirement & Functional Specification Documents
� Supporting the release team during software release and deployment process
� Testing the software as per client�s requirement and ensure bug free software
movement
� Ensure issues are identified, tracked, reported on and resolved in a timely
manner
� Work with client personnel to identify required changes
� Communicate needed changes to development team
� Consistently deliver high-quality services to our clients
� Assist in enforcement of project deadlines and schedules
� Develop relationships with client personnel that foster client ties

- Functionally Consulting for MES in Automotive, Discrete as well as batch

production industries.
- Experience in working for Brown field as well as Green Field MES Implementation.
- Working at Client Side for System Implementation and handover
- Suggest improvements to increase productivity in a manufacturing scenario.
- Understanding business requirements in existing at customer end. Maintaining a
proper flow of development activities by engaging with development team to get the
product through to customer smoothly
- To meet customer requirement within specifications to give effective delivery.
- Having worked as a Financial Analyst
- Preparing daliy trending dashboard and reporting to customer
Worked on Omniture site catalyst-Adobe database

Specialties: - Communication with customer while working onsite,

- Handling on time queries and alteration from customer with managing change in
business requirements.
- Customer Management
- Strong Interpersonal and Soft Skills.
- Excellent Team Player

I take this opportunity to introduce myself as an MBA (PGPM) Graduate in Marketing

and operations as specialization.
Seeking for an opportunity to join a good organization and writing to inquire
whether someone with my background, experience and qualifications can be of
interest to you.
I am absolutely sure that there would be extremely challenging and growth oriented
career opportunities existing in your organization.
All this positively inspires me to explore an appropriate joining with you.
I have 2 years of work experience working as a software test engineer cum business
analyst profile where I have gained lots of technical knowledge of I.T field.

On my part, I can assure you that with my qualification accompanied with the
knowledge and skills acquired during my corse of learning and Internship, I would
be able to make a meaningful contribution to your organization and in turn learn
from the same which will be helpful for my future.

Please find enclosed herein my Resume for your kind perusal. I am looking forward
to an opportunity of meeting your good self and exploring possibilities further.
Thanking you in anticipation and assuring you of my best services at all times.
My latest Resume is attached herewith for your kind consideration.

Thanking You.

Regards,

Rahul

Mob: 8087441408