PROFESSIONAL SUMMARY:

• A dedicated and results - driven health care professional with over 5+ years of experience in the Pharmaceutical, Biotech, Drug, and Device Manufacturing industries. Detail oriented with strong business, planning, validation, implementation skills in the design, development, testing, validation, deployment, and support in the Software development lifecycle of a project-with strong focus in the manufacturing and production of planning applications, Change Control Management testing, and GMP procedures. Exceptional communication and inter-personal skills.
• Good knowledge in Pharma Regulations, SDLC implemented in GxP environment and Support Services.
• Ensured that the teams are producing quality deliverables in compliance with Pharma regulations and GxP. Reviewed key validation deliverables across the SDLC like Validation Plan, URS, SRS, DRR, SCRR, Test plan, Test cases, Test results, Test report, technical installation plans, technical installation reports, System Release notifications, and Validation reports
• Understanding of software development life cycle, expertise and proven track in embedded software testing including vehicle testing and bench testing along with exercising various testing methodologies and software testing life cycle where my experience and capabilities are utilized to the maximum extent while contributing to the company's growth.
• 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 and Software Quality Assurance with profound knowledge of FDA regulations, documenting validation protocols, Documentum, LIMS, AERS
• Extremely knowledgeable with the Software Development Life Cycle, Validation Plans, IQ/OQ/PQ/RTM, validation reports, SOP's, GAMP 5, 21 CFR Part 11, ITIL, risk analysis, testing and implementation of a project
• Reviewed and Validated Computer Systems in compliance to 21 CFR Part 11 and QSR 820
• Experience in generating and reviewing Computer Systems Validation (CSV) Deliverables according to 21 CFR Part 11 and FDA regulations
• Working knowledge of GLP, GCP, GMP, GAMP guidelines in areas of computer or related systems
• Responsible for running Waters Acquity UPLC H-Class System with UV detection instruments.
• Set up and conduct chemical and physical experiments, tests, and analyses, using methods such as HPLC physical and chemical.
• Hands -on Test Method Validation (TMV) and R&D experiences.
• 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.
• 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
• Commissioned various instruments and software such as AAs and software, SoftMax Pro 5.7.
• Expertise in using Documentum, SharePoint, Track Wise, Laboratory Information Management System (LIMS), Windchill, HP Quality Centre, 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).
• Excellent Experience in Validation of Computer applications such as Inform, Clintrial, Clint race, 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.
• 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.
• Experience in Validation with strong background in CSV, Process Validation, Test Method Validation and Equipment Validation.
• Strong understanding of 21 CFR Part 11 drug cGxP requirements including electronic records, electronic signatures, system validation strategies and documentation.
• Excellent communication, writing and interpersonal skills and strong ability to perform as part individually and also as a part of team.
• Knowledge in interpretation of guidelines, audit procedures, Documentation and departmental policies and procedures.
• Experienced in Laboratory Method Validations, Process Validations, Cleaning validations, Building Automations Systems, Microbiology Laboratory Validations, Facility Commissioning, Legacy Equipment Validations etc.

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, Track Wise, 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, Chicago, Illinois

Software Validation (CSV)/ Quality Engineer

Responsibilities:

• Project focused on software validation and instrument qualification along with completing all Data Integrity Gaps. I participated in the Commissioning, Decommissioning and qualification of numerous instruments and software.
• Authored Lifecycle Documents such as SDS, FRS, URS, DQ, CMP, TM, Validation reports, Risk Assessments etc
• 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 analysing possible Issues, Risk assessment and mitigation and maintaining Deviation Records.
• 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.
• Drafted Test Plan, Implementation Plan and Recovery/Back out Plan for Oracle Confidential based application.
• Responsible for good performing of HPLC, developing and technique, and preparation of data summaries for client reports.
• Created templates, procedures, SOPs and manuals for validation including infrastructure qualification, analytical instruments, lab equipment’s, 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.
• Worked with Web Sphere Customer Centre 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.
• 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

Confidential, Canton, MA

Software Validation (CSV)

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 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 equipment’s, 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.
• Hands-on experience with bio-analytical techniques such as HPLC, SDS-CGE, IEF, Fluorescence biophysical characterization.
• Verifying the FMEA and Defining the process flow, &bull.
• Involved in Validation of the labelling 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.
• 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.
• 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.
• Work closely with Project Managers and Global Risk Compliance teams across geographies to produce deliverables required to validate the system and maintain validated status.

Confidential

Validation Analyst

Responsibilities:

• 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

Responsibilities:

• 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 Track Wise 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 (Track Wise) and RFC (SharePoint) are in appropriate status to ensure IT Compliance as per Medimmune standards to comply with FDA regulations.