3 years 10 months of experience in handling Computer System Validation of GxP and Non-GxP applications

Shikha Sharma shikha.sharma503@gmail.com

SUMMARY

3 years and 10 months of experience in validation of GxP and Non-GxP applications in Life Sciences domain with ability to handle multiple projects. Strategic thinker, strong work ethics, self-motivated and a good team player seeking a position to utilize my skills and abilities that offers professional growth while being resourceful, innovative and flexible.Extensive experience in:

Process Compliance & Improvement, Quality Assurance, Life Sciences Regulatory Com-pliance including FDA - 21 CFR Part 11 and GAMP 5.0 Framework, GxP and 21 CFR Part 11 Assessment

Developed CSV packages consisting of URS, FRS, Risk Analysis, IQ, OQ, PQ scripts & Re-quirement Traceability Matrix

Good knowledge of Testing Life Cycle, Test Planning, Test Case Execution, Incident Management

Creating & maintaining validation deliverables for the applications and infrastructure as per CIIT (Compliance infrastructure for Information Technology) guidelines.

Well versed with Pharmacovigilance

Developed SOPs in line with GAMP 5

Managed CSV projects for pharmaceutical industry

Knowledge of Test Planning and Test Management including test environment setup and Integration Testing of new software products.

Held the responsibility of Document Coordinator for IT department for 1.5 years.

SKILL SETCSV, 21 CFR Part 11, ICH Guidelines, Risk Assessment, GAP Analysis, Regulatory Audits, Test Planning, Test Scripts (IQ, OQ and PQ), Defect and Incident Handling, Microsoft Project, Ap-plication Support

PROFESSIONAL EXPERIENCE

Sun Pharmaceuticals Industries Ltd. – February 2015 to till date as CSV Consul-tant

Ranbaxy Laboratories Ltd. - September 2010 to November 2011 and April 2012 to July 2013 as an I.T. Support Consultant.

PROJECT EXPERIENCE

BMC IT Service Management (ITSM)IT service management (ITSM) refers to the various activities – directed by policies, organized and structured in processes and supporting procedures – that are performed by an organization or part of an organization to plan, deliver, operate and control IT services offered to customers.

As CSV Consultant (Validation), responsible for: Authoring the SDLC documents like Validation Plan, Requirement Specification in

association with the client.

Authoring mission critical documents like Validation Plan, UFRS, Test Protocols, and Summary Reports.

Managing the internal team to author, dry run the test scripts involved.

Active involvement in the configuration work-stream to keep the validation ap-proach in sync with the overall objective of the project.

Training employees on CSV methodology and GAMP guidelines

Raising Change Control Request based on the change required in Trackwise Qual-ity Management Application.

BMC Proactivenet Performance Monitoring Tool (BPPM)BPPM is a server monitoring tool which captures the critical alerts after monitoring the server performance and database health.BMC ProactiveNet Performance Management   gets IT out of fire-fighting mode by learning and baselining the behavior of your applications and IT infrastructure, predicting problems before they occur; 

As CSV Consultant (Validation), responsible for: Authoring the SDLC documents like Validation Plan, Requirement Specification in

association with the client.

Authoring mission critical documents like Validation Plan, UFRS, Test Protocols, and Summary Reports.

Managing the internal team to author, dry run the test scripts involved.

Active involvement in the configuration work-stream to keep the validation ap-proach in sync with the overall objective of the project.

Training employees on CSV methodology and GAMP guidelines

Raising Change Control Request based on the change required in Trackwise Qual-ity Management Application.

Learning Management System (LMS)LMS is COTS software which is being used by Ranbaxy Labs to cater all the training related requirements of the organization. The main purpose of this application is to provide on-line Training and evaluation services to the employees so as to make the whole process paper free. As IT Consultant (Validation), responsible for:

SDLC Documentation and Software Validation (Installation\Operational\Perfor-mance Qualification : Infrastructure and Application) as per Guide lines and proce-dures

Reports qualification through SQL Server 2005 Reporting Services which are be-ing required by top management so as to provide Decision Support System in or-der to take decisions

Configuring Activities (content related to training) in the system

Handling documentation for the up gradation of LMS from version 8.2 SP3 to 8.8

Providing Application Support to all the users for troubleshooting

Enterprise Document Archival Management System (EDAMS)Project aimed at electronically managing document archival, issuance, re-archival, destruction workflow with their status that are currently maintained in paper form by the departments. Time spent in documents tracking reduced by 30% and elimination of cost incurred for lost documents.As IT Consultant (Validation), responsible for:

Documentation, Validation, Testing, Data migration and Training.

Pharmacovigilance (PVG)Obsoleting the third party vendor by leveraging Global Learning Platform for PVG Training and shifting of Ranbaxy Pharmacovigilance Website www.RanbaxyPharmacovigilance.com on our premises. More than 100% increase in the Training completion records. This process transformation resulted into more the 100% improvement in Scope

Enhancement and Training Completion, Significant Cost Saving on Licenses & AMCs and IP protection.

As IT Consultant (Validation), responsible for: Preparation, Validation, Testing, Data migration and Training.

CLP Label Printing SystemIt is a web application which is used in printing of the labels required during the manufacturing process in Ranbaxy for various locations. The labels are generated with bar codes to ease the process.As IT Consultant (Validation), responsible for:

Documentation, Validation and Testing

KEY ACHEIVEMENTS Excellent Presentation skills with experience of providing training to end users,

Business Administrators and other team members.

Creation of the entire validation documents like: SLRA, FRS, FLRA, RTM, PVP, CSD, QP, VSR and SRC and end to end manual testing (IQ, OQ and PQ : Application as well as infrastructure), Functional, Module, Integration of applications.

Exceptionally well organized with a track record that demonstrates self-motiva-tion, creativity and initiative to achieve both personal & corporate goals.

Excellent Microsoft Office suite knowledge with extensive experience of working with MS SQL, MS BIDS, DFD and MS Projects.

Strong quantitative ability and excellent team working & communication skills.

EDUCATION MTech (Computer Science and Engineering) from Chandigarh Group of Colleges,

Landran, Mohali, Punjab in 2013-2015 securing 72.3%. BTech (Computer Science and Engineering) from Chitkara Institute of Engineering

and Technology, Rajpura, Punjab in 2006-2010 securing 73%. 10+2 from Satluj Public School, Panchkula (C.B.S.E.) in 2006 securing 68% marks. 10th from Manav Mangal School, Panchkula (C.B.S.E.) in 2004 securing 63%

marks.

PERSONAL DETAILS Date of birth: 11-Mar-1989 Marital Status: Married Contact No: +918826991126 Address: B-70, Siddharth Kunj Apartments, Plot No. 17, Sector 7, Dwarka Personality Traits: Very good analytical and logical skills, Practical Approach

towards problem solving, Team player