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Project Customer Service

Philadelphia, PA
January 06, 2014

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Sajla Singh

** ***** ***. ****: 609-***-****

Lawrenceville, NJ 08648 C ell: 609-***-****

Qualification Profile

C o mputer System Validation (CSV), QA and Software Testing professional (Lead & SME) with over 13 years of experience. Goal is to

acquire a lead position in QA and software testing (Testing and User acceptance, Assess ment and Re m ediation) associated field where

m y experience in software testing strategy and process, perfor ming quality review of User Require ments and UAT documents, quality

audits / reviews, FDA validation, keen attention to detail, strong managerial expertise, and excellent interpersonal skills, Trial and drug

specific knowledge will be of benefit to deliver a high quality product, and excellent customer service while pro moting the advance ment

of the co mpany in the industry.

• Proven people leader with excellent interpersonal and communications skills

• Creative problem solver with the ability to deliver against requirements

• Resourceful and Self-starter who can multi task several objectives

• Performed assessment and remediation activities under Consent Decree.

• Experienced with audit tracking regulations (Documentum, MIDAS and other client proprietary

products) and CFR Part 11 regulations.

• Ability to handle multiple areas of responsibility. Coordinate production releases between various

internal team (Quality, IVRS, Clinical, EDC, Inform) and vendors.

• Expertise in following and maintaining SDLC, CSV, testing strategy, quality audits, requirement

reviews, and User Acceptance Testing

• Expertise in using IMB Rational tools (Clear quest, Clear case)

• Responsible for tracking defects (pre and post production) and creating metrics for leadership

team on the severity of the incidents for all different vendors (Incidents tracked by Clear quest

and client proprietary tools).

• Trial and drug specific knowledge

• Trained in Software Testing and Project Management

• Experience in working in an FDA regulated environment

• Expertise in providing risk analysis and technical impact on post production changes / updates.

• Expertise in efficient resourcing of projects (pre & post production) within team.

• Worked using GAMP5 methodology.

Validation Analyst / Assessor– Integrated Project S ervices / McNeil.

Fort Washington, PA (August 2013

– Oct 2013


Responsible for assessing the co mputer systems used that fall under C onsent Decree.

Responsible for creating / developing the remediation plan based on the assess ment.

Worked on the assess ment for the training system used at McNeil


Creating and maintaining relevant documents required per remediation plan.


Lead UAT Analyst (IVRS / IWRS QC & Testing) R esearch Phar maceutical S ervices / Merck & C o.,



West Point, PA ( March 2009 – April 2013)

Responsible for following and maintaining SDLC for all client projects.

Responsible for creating / developing and maintaining Validation and UAT standards and its related

documents following GDP.

Creating and maintaining standard Validation test plan, test sum mary report, test scripts.


Creating and maintaining validation checklists


Creating standard process for testing configurable items


Creating and maintaining validation m etrics (m etrics for number of issues, severity and status of


issues, etc)

Tracking change requests for post production changes.


Managing and assisting UAT project assignments within GDP and G CP

Receipt of resource request from vendors


Assigning UAT specialists to perfor m UAT activities (base and post production change controls)


based on e mployee workload, experience and co mplexity of the project.

Track current projects with regards to the time lines.


Audit preparation and responses.

Responsible for preparing and co mpiling UAT documents for audits.


Actively participating during audits. Responsible for answering questions related to UAT


processes, UAT documents

C o mpile audit response for audit findings.


Quality review and approval of

User Requirements across all vendors.


UAT documents before, during and after the execution of a UAT


Managing and assisting UAT project assignments

Receipt of resource request from vendors


Assigning UAT specialists to perfor m UAT activities (base and post production change controls)


based on e mployee workload, experience and co mplexity of the project.

Track current projects with regards to the time lines.


C ollaborate with Sponsor, external vendors and internal functions to develop scenarios for testing


Create and execute User Acceptance test scripts within published study / system project timelines for

IVRS / IWRS products for different vendors.

Address and resolve UAT findings with vendor and core team.


Liaise between IVRS Operational team and the vendors for UAT process and procedure .

Serve as Technical Subject Matter Expert (SME) within the IVRS team.

Perfor m and assist in providing validation impact on post production changes

Mentor team m e mbers with UAT process, assist and conduct user acceptance testing across different


C ontributes and suggests process improve ment, attend m e etings related to project timelines as necessary.

C onfor m with GMP and GDP practices

Drug Supply Coordinator– R esearch Phar maceutical S ervices / Merck & C o., Inc.

West Point, PA ( September 2008 – March 2009 )


Independently m onitor and coordinate all activities associated with clinical supplies for designated


Execute clinical supplies activities such as ordering, processing and release of drug at all G CSO sites.

Interact with Clinical, subsidiaries, CROps, regulatory and other departments to address drug supply

related issues.

Participate on the IVRS core team to deter mine IVRS milestone and timelines to contribute to the

development of MIVRS study specific require ments and shipping procedures.

Ensure proper documentation is provided for already generated orders, allocation schedules, etc before it

is assigned to appropriate G CS O sites.

Responsible for m onitoring REDs as required.

Responsible for m onitoring resupply, trigger levels for IVRS studies and tracking study enrollment and

discontinuation rates to adjust de mand / supply needs.

Analyze and anticipate project problems as they relate to clinical supplies.

C onduct study closeout procedures with collaboration from Clinical and GMP.

Represent G CS O on cross functional teams as appropriate.

Address replace ment requests.

Assist in drug reconciliation process.

Assist in study closeout process.

Software Test Engineer United BioSource C orporation – Clinical Technologies Group, Langhorne, PA

( January 2008 – June 2008 )

Work on special R&D project.

Notification Platfor m.

This tool would help the developers create a system with configurable notifications.


Test the Forecasting tool.

This tool would help the user to deter mine and m onitor the drug supply for their respective study.


Evaluate the use of the testing tool – Gigamoto, within the co mpany.

Assist in creating standard testing scenarios for the IVRS products.

Group Leader, Software Testing ALMA C Clinical Technologies, Inc., Yardley, PA

( May 2005 December 2007 )

Ensured IVR system development m et FDA and client requirements

Review test documents to ensure that they were part 11co mpliant.

Assist in client audits.

Manage and support client UAT’s.

Provide support during and after the IVR imple mentation.

Created & maintained standard and study specific test / validation plans and test scripts.

Tested and helped assist in testing of the standard m odules related to the IVRS & the R&D projects.

Train and m entor team m e mbers. Assist the test department in identifying and documenting the test

team m e mber training.

Prepare and provide orientation to new e mployees.

Review the work of new e mployees until dee med trained.


C onduct and participate in project m e etings, lead team m e etings, identify, analyze and report test

m etrics. Identify corrective actions and assist with preventative m easures.

Ensure the understanding, co mpliance and implementation of SDLC.

Use the incident and Deviation reports to m onitor the quality of the test team deliverables.

Assist the Director and the Test Manager with the imple mentation of the corrective m easures.

Participate in ongoing process improve m ent (identify and imple ment reco m m endations).

Participate in the review of SOP’s and review and creation of Working Instructions.

Develop corrective and development action plans for staff as needed.

Define logical, risk based test approach for testing internal and external software programs

Senior Software Test Analyst – Interactive Clinical Technologies, Inc., Yardley, PA

( October 2004 – May 2005)

Senior Validation Analyst – Interactive Clinical Technologies, Inc., Yardley, PA

( February 2002 – October 2004)

Train and supervise Validation Analyst

Write and execute test cases within strictly defined timelines

Work as part of a project team to ensure client projects are delivered on time and within budget

Participate in requirements, system and database design meetings

Create and maintain test documentation

Assign project tasks and ensure project deliverable timelines are met

Maintain significant levels of validation documentation

Participate in client audits and assist quality assurance with responses to audit findings

Validation Analyst – Interactive Clinical Technologies, Inc., Yardley, PA

( May 2000 – February 2002)

Ensured IVR system development met FDA and client requirements

Developed and executed validation test plans within client established timelines

Assisted Group Leaders in training new Validation Analysts

Database Help – F.Schu macher & C o m pany, Cranbury, NJ

( October 1999 – November 1999)

Performed proof reading for database material.

Inputting proof read data using Microsoft Access and Schumacher proprietary software.

Laboratory Operations Assistant, Bristol Myers S quibb, Princeton / Hamilton, NJ

( September August 1993 December 1998)

Maintaining the database for lab Investigator list

Inputting data for hematology, Urine and chemistry

tests using BMS proprietary software.


Helped update the customer database in preparation

for the new Lab Information Management System (LIMS).


Microsoft Office (

PowerPoint, Excel, Access, Word, Visio and Outlook), Access97,

Query Analyzer,


SQL Server 2000, .Net

Oracle – Relational database

Microsoft SQL Server Enterprise Manager

IBM Rational Clear Quest and Clear Case

Windows 2000 and Windows XP

DCS Master C ontrol

21 CFR Part 11

G CP Training

Basic Project Manage m ent and Software Testing Efficiencies Training

Supply Forecasting Tool

Testing Tool – Gigamoto

Merck proprietary software.


Bachelor of Science, Computer Information Systems,

New Jersey Institute of Technology, Newark, NJ

Bachelor of Science, Zoology. Ranchi University, India


Available upon request.


Contact this candidate