SUMMARY:

Professional experience with Validation of Software, Computer Systems/Testing used in Laboratories, Clinical, Pharmaceutical/ Medical Devices and Biochemical Industries. Excellent working experience in validating the computer systems in as per CAPA, FDA regulations and GLP, GMP, GCP guidelines. Contributed to the success of Inform, Clintrial, Confidential applications and managing the team members by motivating the team and by conducting meetings, periodic review.

• Excellent Experience in Validation of Computer applications such as Inform, Clintrial, Clintrace, Oracle Confidential, Routers, Switches, Remedy, Sample Manager, Documentum, LIMS, Data Integrity, Pharmaceuticals/Biologics
• Experience in Developing and enhancing the Standard Operating Procedures (SOPs) as a part of the SOP program.
• Expertise in conducting Risk Assessment, 21 CFR Part 11 Assessment, Security Assessment, and documenting as per GAMP 5 guidelines. Heavy emphasis on Computer Systems Validation, Instrument/Equipment Validation, Cleaning and Process Validation and Software Quality Assurance with profound knowledge of FDA regulations, documenting validation protocols, Documentum, LIMS, AERS
• Develop Software Test Plans (STP) and protocols (both manual and automated using scripts), Software Requirement Specifications (SRS), Software Development Plan (SDP), Software Design Specifications (SDS), Customer Requirement Specifications (CRS), Software Configuration Control (SCC), and software manuals. 
• Hands - on Test Method Validation (TMV), and R&D experiences.
• Worked with many Automation and process systems like DCS, PLC, HMI, custom software systems etc. for unit operations like compounding, batching, cleaning, freeze drying, SIP, filling, packaging. 
• Develop test scripts and execute V/V software tests both automated (Rational Visual Test 6.0) and manual. 
• Expertise in using Documentum, Sharepoint, TrackWise, Laboratory Information Management System (LIMS), Windchill, HP Quality Center, Adverse Event Reporting System (AERS). 
• Experience in documenting User Requirements Specifications (URS), Functional Specifications (FS) and Design Specifications (DS) documents. 
• Expertise in documenting Design Review (DR) and Qualification Protocol (QP), Technical Writing. Excellent experience as Validation Specialist and in-depth involvement in writing test scripts for Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ). 
• Experienced in Laboratory Method Validations, Process Validations, Cleaning validations, Building Automations Systems, Microbiology Laboratory Validations, Facility Commissioning, Legacy Equipment Validations etc.  
• Excellent understanding of Software Development Life Cycle (SDLC). 
• Hands on experience in Manual Testing of various applications and developed Test Plans, deliverables, entry and exit criteria and documented the User Acceptance Testing based on the User Requirements and also assessed the risk and security aspects for the application. 
• Well versed with MS Office. Excellent oral and written communication skills.

TECHNICAL SKILLS:

Methodologies: Agile, Waterfall, V-model, Spiral 

Regulations GMP: FDA 21CFR-Part 211, GLP (21CFR Part 58, QSR (21CFR Part 820), ERES (21CFR - Part 11, Gamp 4/5, SOX 

Software: MS Office, MS Project, MS Visio, Labware LIMS, Watson LIMS, Sharepoint, eRoom, Oracle Argus Safety AERS, Spectrophotometer, Astra Data Acquisition software, Agilent Chemstation, Empower, SQL, TrackWise, LIMS, Documentum (V 6), Windchill (V 9.1), MATLAB, JMP, SAS 

Testing Tools: Quality Center, Crystal Reports, Win Runner 6/7.6, Load Runner, Test Director 

Programming: C, C++, SQL, PL/SQL, Visual Basic, PL7 ladder logic 

O.S: Unix, Linux, Windows DOS 

Database: Oracle 8/9i, MS Access, SQL

PROFESSIONAL EXPERIENCE:

Confidential, Mahwah, NJ

Software Validation (CSV)/ Quality Engineer

Responsibilities:

• Documented URS, IQ, OQ and PQ for Version Control and Data Solutions systems. Reviewed URS and FRS documents for Jira application. Documented Validation Plan, Test plan, Functional Specifications, Qualification Protocol and Test cases. 
• Participated in meetings with IT Project Manager, Validation Analyst in order to track project status and to verify the project progress complies with the project schedule. 
• Created templates, procedures, SOPs and manuals for validation including infrastructure qualification, analytical instruments, lab equipments, spreadsheet and SAP based applications. 
• Created Data Migration scripts and monitored the extraction and transfer process. 
• Gathered requirements, reviewed and approved Requirements Specification document as part of IT tools validation. Reviewed and approved related documents such as Validation Plan, Test plan, Requirements Specification, Functional Specifications, Qualification Protocol, Test cases.
• Used Quality Center for managing Requirements, Test Plan and Test Cases. Wrote Test plan, validation plan for the validation of IT tools. 
• Reviewed the Functional Specifications document for DOORS. Reviewed the SOPs and policies and regulations. 
• Involved in Validation of the labeling application and associated hardware in accordance with FDA's 'General Principles of Software Validation' and 21 CFR part 11 compliance 
• Authored and reviewed Design Specifications and Functional Specifications as per the needs of the client sites. 
• Developed Validation Protocols (IQ, OQ, PQ) as per the specifications and requirements. 
• Responsible for handling the objective evidence, managing the associated deviations and escalating the system issues. 
• Involved in analyzing possible Issues, Risk assessment and mitigation and maintaining Deviation Records. 
• Initiating and updating Change Control tickets for CAB and CCB reviews as per Quality System Impact procedures. 
• Authored, reviewed and maintained Traceability Matrix for various testing cycles planned for multiple global level site deployments. 
• Developed Training Plans and SOPs as per FDA Quality System Regulations (QSR), ISO 13485, ICH Q10. 
• Participated in the production support activities and Continual Service Improvements (CSIs) of the systems and processes. 
• Trained Testers and Business Users on Test Script Execution and Evidence Handling as per FDA's Good Documentation Practices. 
• Involved in management, maintenance, retrieval and archival of documents and records electronically using SharePoint. 

Confidential

Validation Analyst

• Reviewed Change Requests for different bugs and fixes those arise during the Oracle Confidential Release Management Project. 
• Reviewed, organized Change Requests and approved after verification of completeness of documentation. 
• Assessed Quality, Compliance, and Application, Business and Infrastructure impact of the Change and also the impact if the fix is not moved to Production. 
• Assessed Risk and prioritized Change Requests and ensured the Change Requests are moved accordingly. 
• Drafted Test Plan, Implementation Plan and Recovery/Back out Plan for Oracle Confidential based application. 
• Worked with Web sphere Customer Center for maintaining record of the customers across the enterprise. Conducted Load testing and monitored performance scenarios with HP LoadRunner. 
• Worked with the Development team, Change Management team, Technology, Business and Compliance approval teams to move the Change Requests to different environments. 
• Worked with the developers in creating Setup Logs, Patch Logs for the fixes that involved Setups and Patches. 
• Reviewed and enhanced Change Requests created by the Change Control team. 

Confidential

Validation Specialist/Test Analyst

• Monitored the testing conducted by QA dept. and documented the Validation Summary Reports.The project at Medimmune mainly involved working on Regulatory applications. 
• Involved in coordinating the approval of IT for Insight Publisher Upgrade through authorized Request for Change- RFC. 
• Co-ordinated with Regulatory Operations to open a new Validated System Change Request in TrackWise to document the implementation of Insight Publisher Upgrade. 
• Drafted the Installation Qualification Protocol (IQP) as per release notes provided by for implementation of insight Patch. 
• Involved in review, update and pre-approval of IQP and OQP by uploading the documents in Aegis EDMS involving System Owner, Validation, Information Technology, and Quality Assurance 
• Involved in the post execution documentation (as per GDP) of executed IQP, and OQP and coordinated with System Owner, Validation, Information Technology, and Quality Assurance for post approval. 
• Assured that the VSCR (TrackWise) and RFC (SharePoint) are in appropriate status to ensure IT Compliance as per Medimmune standards to comply with FDA regulations.