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Swetha Validation

Validation/Compliance Analyst - AstraZeneca

Hackensack, NJ


o 7 years of experience in Pharmaceutical Environment with expertise in Computer System Validation (CSV), Testing and Technical Writing with strict adherence to GAMP&cGMP regulations. 
o Knowledge and understanding of21 CFR part 11 (Electronic Records, Electronic Signatures, Audit Trails and Security events), 21 CFR part 210 and 211 and associated FDA Regulations and EU guidelines. 
o Extensive experience with validation & integration of Quality Management System, Scientific Data Management System (SDMS), Learning Management System (LMS), Document Management System (DMS), Laboratory Information Management System (LIMS), Adverse Event Reporting System (AERS) and Clinical Data Management System (CDMS), Documentum and Track wise Software. 
o Excellent understanding of the software development lifecycle (SDLC), Computer Validation Life cycle (VLC)and Manual Testing. 
o Proficient in development and execution of Standard Operating Procedures (SOPs), Validation plans (VP), Validation Protocols (IQ, OQ and PQ), Requirement Traceability Matrix (RTM) and Summary Reports (Validation and Test Summary Reports, VSR/TSR) in various pharmaceutical companies. 
o Experience in validating laboratory instruments like Spectrophotometers, High Performance Liquid Chromatography (HPLC), Centrifuges, Autoclaves, Sterilizers, Incubators, Depyrogeneration oven and refrigerators. 
o Substantial experience in developing and reviewing User Requirement Specifications (URS), Functional Requirement Specifications (FRS) and Design Specifications (DS), Test plans, Test cases, test scripts, Test reports and Test requirements. 
o Professional experience in validation practices with good understanding of cGxP (cGMP, cGLP, cGDP, and cGCP) standards, Gap Analysis and Remediation Plans. 
o Extensive experience in developing Test plans, Test cases, test scripts, Test reports and Test requirements. 
o Experience with Corrective Action and Preventive Action (CAPA) investigation to identify and evaluate the problem or non-conformance. 
o Proficient in performing UAT, integration testing, functionality testing, D2D testing, E2E testing and black-box testing and in using automated testing tools like Quick Test Professional (QTP), Win Runner and Load Runner. 
o Expertise in using SQL for data validation and manipulation and managing records. 
o Substantial experience in test management, bug tracking, reporting systems and documenting change Requests using HP Quality Center. 
o Proven efficient to work independently and in a team, possessing strong multi-tasking, communication, technical, interpersonal skills and documentation skills in compliance with Good Documentation Practices (GDP).

Work Experience

Validation/Compliance Analyst

Wilmington, DE

February 2011 to Present

AstraZeneca is a leading research based biopharmaceutical company known worldwide for its development, manufacturing and prescribing a great range of medicines to combat severe diseases with a mission to make a real difference to people's health. 
As a member of Computer Systems Validation team, I was responsible in validating the software applications and equipment, worked on various services such as reviewing reports, track requirements in compliance with FDA regulations. 
➢ Responsible for documenting and reviewing Validation deliverables to assure compliance with 21 CFR Part 11 (Electronic Signatures & Records) and FDA Regulations in Software Development Life Cycle (SDLC). 
➢ Interacted with the R&D team in gathering and documenting User Requirements Specifications (URS). 
➢ Created and authored documentation for all aspects of the computer systems validation lifecycle in accordance with FDA regulations, particularly 21 CFR Part 11, including: Validation Plan and Protocols for Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ) and Validation Summary report (VSR) and identification of deviations. 
➢ PreparedcGMP documentation and reports in support of cleaning validation. 
➢ Designed Validation of Instrument Systems and ensured compliance with quality system requirements. 
➢ Performed ERES risk assessment for electronic records and electronic signatures to assess 21 CFR Part 11 applicability and compliance. 
➢ Prepared Requirement Traceability Matrix (RTM) to track requirements and to co-relate with the conducted test cases and defects using Quality Center. 
➢ Developed Working Instructions for different users of the application and assisted in drafting the Standard Operating Procedures (SOP). 
➢ Designed the Training Plan for the End users and Local Administrators for Track Wise. 
➢ Excellent in identifying components of pharmaceutical manufacturing and packaging equipment. 
➢ Designed, developed and implemented Test Plans, Pre/Post executed scripts, Test cases;Test Reports generated by the LIMS application for compliance with 21 CFR part 11 requirements. 
➢ Performed Gap Analysis and Remediation procedures for LIMS modules that helped in preventing bugs. 
➢ Responsible for CAPA management and corresponding change control procedures. 
➢ Assisted in performing investigations and optimization for non-compliant trouble shootings and coordinated scheduling of equipment sampling within validation group. 
➢ Attended daily status meetings with Project management on testing updates.

Validation Specialist

Gilead Pharmaceuticals
Fremont, CA

March 2010 to January 2011

Gilead is one of the leading pharmaceutical companies which are inspired by the vision to discover, develop and commercialize small molecule therapeutics to address unmet medical needs for patients living with life-threatening diseases around the world. 
The project involved the equipment validation of Autoclaves, Spectrophotometer from Agilent, HPLC and GC with Chemstation Software from Agilent which employed a distributed control system. The project also involved interfacing lab instruments with the Labware LIMS and to make sure the application was in compliance with FDA regulations. 
➢ Prepared documents for all aspects of the computer system validation life cycle, in accordance with FDA design control and regulations, particularly 21 CFR Part 11. 
➢ Developed and executed IQ, OQ and PQ protocols, prepared the VSR to summarize all the documentation and instrument validation activities. 
➢ Gathered URS and FRS for the Chemstation Software and its integration with LabWareLIMS. 
➢ Involved in drafting the Requirement Based Risk Assessment along with System Owner, QA, and Developer. 
➢ Assisted in initiating and conducting Gap Analysis and Remediation Plan for lab equipment and software interfaced with LIMS for 21 CFR Part 11 compliance and prepared Deviation Reports. 
➢ Reviewed and carried out UAT, Positive testing, Negative testing, Regression testing for the Chemstation software using Quatity Center tool. 
➢ Involved in updating related SOPs according to the change involved in the project. 
➢ Assisted with the maintenance of validation testing on HPLC, GC spectrophotometers, autoclaves, equipment sterilizers, depyrogenation tunnels and ovens. 
➢ Created Requirement Traceability Matrix(RTM) which helped to see whether the user requirements were met with the business requirements. 
➢ Extensively used Enterprise Data Management platform Documentum for maintaining validation life cycle documents. 
➢ Prepared CAPA plan, test cases, test scripts, test summary reports for overall product, part wise assessment and improvement and reported concerns if any to the suppliers. 
➢ Suggested process parameters for process optimization, process control and product development. 
➢ Involved in up gradation of the software's of the laboratory instrumentation and overcame the technical obstacles. 
➢ Organized, developed, and managed multiple projects with effective time management. 
➢ Conducted meetings to discuss compliances with the FDA rules and regulations.

Validation Engineer/Technical Writer

Collegeville, PA

February 2008 to January 2010

Wyeth, global enterprise with major research and development programs targeting the discovery and delivery of innovative pharmaceutical, consumer healthcare, vaccine and nutritional products to serve the health needs of people in more than 145 countries. 
This project involved the evaluation and calibration of the equipment and procedures used in development and production of a variety of products. It included validation of (AERS) to report adverse events and monitor the performance of their products proactively, by observing trends and identifying safety issues. 
➢ Developed and reviewed a Validation Master Plan (VMP) for AERS (Adverse Event Reporting System) in compliance with FDA regulations as well as writing documentation for AERS. 
➢ Gathered UAT scripts for LIMS according to the SOPs. 
➢ Drafted the IQ, OQ, PQ as per URS and SRS in close association with the QA team. 
➢ Reviewed test cases and scripts and documented the results as per the FDA regulations. 
➢ Involved in preparing compliance report about existing status of the cGMP, GCP and GLP. 
➢ Drafted SOPs to incorporate GxP and 21 CRF part 11 requirements. 
➢ Monitored the Design, Manufacture and Installation of all medical devices in the process to satisfy 21 CFR 820 regulations. 
➢ Prepared and reviewed Validation Summary Report (VSR) to summarize the overall validation effort. 
➢ Involved in ETL (Extraction, transformation and loading) of the product data into Register. 
➢ Reviewed documents (Project Plan, Test Plan, Test Cases) and provided input on documents pertaining to Migration of Relsys ARGUS 2.9, as the system will be upgraded to v4.2 
➢ Tracked the training records of individuals (Project Manager, Technical Lead, Document Liaison) working on the projects. 
➢ Created Summary Reports for all the projects as part of a close out report stating the issues & risks mitigation and track down of all deliverables created, their completion and approval.

Validation Test Engineer

Rasi Labs
Somerset, NJ

March 2006 to January 2008

Rasi Labs has the proven ability to combine advanced nutrition science and innovative technologies for the development and marketing of dietary supplements to various leading companies. 
This project included the testing of systems, establish validation standards, develop testing protocols, prepare equipment, document test results and maintain records for later analysis. 
➢ Coordinated with the project manager to write the Validation Master Plan. 
➢ Maintained and executed validation guidelines for testing the GMP, GCP, GLP sensitive transactions. 
➢ Developed IQ, OQ and PQ test scripts to test the application following strict GDP and 21CFR Part11. 
➢ Responsible for the overall coverage of requirements of User Requirement Specifications (URS) and Functional Requirement Specifications (FRS). 
➢ Developed and analyzed Test Scripts to check the functionalities of the application for 21CFR part 11 Compliant. 
➢ Responsible for developing the Requirement Traceability Matrix (RTM)to trackrequirement during QA testing phase. 
➢ Performed Risk Assessments to verify whether the systems are Quality impacting and Part 11 compliant. 
➢ Analyzed and documented detailed program information working and interfacing with software developers and members of various other dependent departments. 
➢ Performed Manual Testing of the application prior to automate testing using Win Runner. 
➢ Responsible for allocation of test assignments to the team members.


Bachelors in Pharmacy

JNTU University

Additional Information

Computer systems validation 
21 CFR part11, 210,211, GxP, SDLC, Validation Protocols (IQ, OQ, PQ), URS, FRS, QTP, validation master plan, Test scripts, SOP's, RTM, AERS, TrackWise, LIMS, summary reports, executing test scripts for validation, LMS. 
Test Tools Quality Center. QTP, Load runner and Wind Runner. 
Medical Instrumentation ECG, Glucose Sensor, Pulse Oximeter,Biopac EMG, EEG, EOG, real-time PCR, IHC, tissue perfusion 
Operating Systems Windows XP/2000/ME/98,Mac, UNIX/Linux 
Programming C, C++, SQL, PL/SQL, HTML. 
Browsers Internet Explorer, Netscape Navigator, Firefox 
Office tools MS Word, MS Excel, MS PowerPoint, Chemdraw, JMP-SAS (statistical tool for DOE), SharePoint, Vision, Documentum.