SUMMARY:

• I have over 8 years of expertise, seeking a goal oriented, and challenging position as a Developer/Business Analyst, where I can add value to the Validation, Technical Writing, gathering requirements and Quality Assurance processes.
• Experience as a Developer / Business Analyst in Pharmaceutical environment with concentration in Computer System Validation (CSV), Equipment Validation with strict adherence to FDA regulations.
• Professional Profile: Working experience in FDA regulated environment and pharmaceutical companies with good understanding of cGxP (cGMP, cGDP, cGLP) standards and Risk based validation.
• Experience in creating Compliance deliverables like Validation Master Plan (VP), User/Business Requirements Specification (URS), Functional Requirement Specification (FRS), Design Specification (DS), Writing test scripts, Executing tests and Construction Summary Reports for Installation Qualifications (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), Test Summary Report (TSR), Gap Analysis, Remediation Plans, Requirements Traceability Matrix (RTM) for validations in various pharmaceutical companies.
• Proficient in Business Requirement gathering, Project Management, Business Process Flow, Joint application design (JAD), Business Process Modeling and Business Analysis, Technical Documentation and RTM
• Strong skills in creating Use Cases, Sequence Diagrams, Collaboration diagrams, Activity Diagrams, Class Diagrams and Test Cases.
• In - depth understanding of System Development Life Cycle (SDLC), Unified Modeling Language (UML), Object Modeling Technique (OMT) and Object Oriented Analysis (OOA)
• Writing reports based on Requirements Traceability Matrix.
• Strong understanding of 21 CFR Part 11, Quality System Regulations (QSR), cGMP, GxP (GMP, GLP, GCP), GAMP requirements including electronic records, electronic signatures, system validation strategies and documentation.
• Extensive knowledge of Risk Analysis by identifying the vulnerability points and recommends Disaster Avoidance during and after installation.
• Strong validation engineering experience with Laboratory Information Management Systems (LIMS) and Integration with equipment’s (HPLC, GC, FTIR, Spectrophotometer, PH meter), Electronic Document Management System (EDMS) and Adverse Event Reporting System (AERS)
• Experience in writing testing methodologies of analytical lab equipment such as HPLC, Autoclaves, Incubators, Ovens and pH meter, Fermenters, Filtration and Biochemical Reactors.
• Working knowledge of designing & implementation of all QA test strategy plans manually and using automated test solutions for client/server and web applications with HP Quality Center, QTP (Automation & Testing) and manual testing.
• Experience in conducting User Acceptance Testing (UAT), Smoke Testing, Regression Testing, Performance testing, and Functional Testing.
• Formulated black box test strategies, prepared comprehensive test plans, test case documents, and test scripts.
• Good understanding of Software Development Life Cycle (SDLC) and Testing Life Cycle (TLC).
• Complete knowledge on implementing computer system validation, where I did gap analysis, coverage assessment, risk assessment, mitigation plan and remediation plans.
• Finalized the corrective action Prevention action (CAPA) plans with the vendor.
• Intense knowledge of tractability matrices and exposure to Quality Control, TruCompare and Quality Assurance.
• Extensively performed Data Migration concepts for legacy systems.
• Experienced in development and execution of Test Plan, Test Scripts and Test Cases based on Design document and User Requirement document for testing purposes
• Skilled technical writer and editor. Expertise in performing GAP analysis to comply with 21 CFR Part 11.
• Working knowledge of SharePoint, e-Room, Documentum, Trim Context Dataset on a regular basis for document storage and retrieval.
• Assisted in developing sessions in LMS for new projects with Platue and Genensis.
• Orchestrated construction of secure lab containing validated/qualified devices for user acceptance testing
• Strong communication, organizational and time management skills.
• Performed all the reviews of documents with Due Diligence.

TECHNICAL SKILLS:

Compliance: 21 CFR Part (11, 210, 211, 820, 56, 50), GAMP, cGMP, GxP (GMP, GLP, GCP), QSR, ISO9000, PMBok, ICH Guidelines.

Business Tools: MS Office, MS Project, WordPerfect, Outlook, Acrobat, MS VISIO, Share Point, Snipping Tool, Snag-IT, TrackWise, CoBIT, RiskIT, ITIL software development.

Computer System Validation: SOP S, VMP, URS, FRS, DS, IQ, OQ, PQ, Test protocols and Summary Reports, RTM, Audit Trails and VSR.

Methodologies: Software Development Life Cycle (Waterfall, Spiral, AGILE model, Agile Scrum)

Operating Systems: Window XP/2000/2003/XP/Vista, UNIX

Databases: Oracle MySQL, MS Access, SQL Server

Web Technologies: VB Script, XML, HL7, HTML, Perl, Java Script, Load Runner.

Medical Device Validation: QSR, ISO 13485, ISO 9001, ISO 10993, ISO

Validation Applications: LIMS, EDMS, AERS, EduNeering LMS, LIS, Siebel CRM, Oracle People Soft (Adverse events reporting systems), Oracle people Soft call center. EDHR.

PROFESSIONAL EXPERIENCE:

Confidential, Fort Worth, TX

LIMS Developer/Business Analyst

Responsibilities:

• Reviewed the previous documentation for each module in the R&DLIMS application, and upgraded to the current template formats.
• Worked on the MS Visio, to draw the workflow diagrams, Process flow diagrams for URS and FRS.
• Maintained and ensured the accuracy of the requirements in URS and FRS by assigning the critical parameters to each of the user and functional requirements.
• Documented User and Functional requirements on individual modules of R&D LIMS such as, Formulation Batch Modules (FBM), Stability Protocol Module (SPM), Integrated Stability Module, LIMS QA Module, Integrated Stability Update Module (ISUM), R&DLIMS Admin Module and Packaging Module(Labeling and Barcode)
• Worked on Labeling System to generate barcodes to the finished products for tracking in Packaging Module.
• Queried on the application to find out the different stability studies and generate various summary reports.
• Participated in many project meetings providing the valuable inputs related to the regulatory requirements such as, Part 11 Electronic Records and Electronic Signature compliance, SOX compliance and importance of documentation, project deliverables, and validation deliverables.
• Worked on reviewing High Level Classification Documentation (HLCD). Helped my teammates to understand the High Level Risk Assessments (HLRA’s) Document in conversion into new HLCD’s format.
• Initiated the GAP analysis to identify the changes to be included in the current upgrade functionalities from the Control Change Request (CCR) log, Assigned tasks to work on Data Privacy, IT Security knowledge, Test Specifications (IQ, OQ, PQ), Application Design Specifications and Operational Handbook.
• Worked on the determining the custom requirements for e-Learning with LMS for stability studies.
• Worked on MS Project, to update the timelines and to schedule the project deliverables in a timely manner.
• Helped our Project Manager in determining the project risks and calculated the risk occurrence and risk probability.

Confidential, Somerset, NJ

LIMS Developer/Business Analyst

Responsibilities:

• Involved in all phases of Computer System Validation (CSV) Life Cycle to comply with FDA regulations particularly 21 CFR Part 11.
• Determined compliance of electronic records and electronic signatures with 21 CFR part 11 and also checked the management system protocols to be in compliance FDA Regulations GMP/QSRs, ISO 13485.
• Involved in the complete life cycle from Planning, Organizing, Specification, System Assessment, Design, Construction, Acceptance Testing, IQ, OQ (Unit and Integration Tests), PQ, System Operation and Maintenance.
• Worked on developing the User Requirements Specifications (URS), System Requirements Specifications (SRS) and Design Specifications as per the client requirements.
• Developed High-Level classification documents (HLCD) based on risk assessments.
• Worked on vendor assessment to verify the validation effort required for the client.
• Suggested risk based validation approach for validating the configurations required by the client.
• Performed deviation investigations and resolved issues by doing root-cause analysis and implemented CAPA, re-validation as necessary.
• Worked on writing Operation Qualification (OQ) Specification, Performance Qualification (PQ) Specification scripts, System Requirement Specification (SRS) and Workflow diagrams for validation.
• Coordinated various teams during executions to reach out to the testers and solve any issues.
• Managed project timelines and keep track of all the team members and status updates.
• Documented Requirements Traceability Matrix (RTM) to track the requirements.
• Involved in performing Risk Assessment and proposed improvement suggestions on Validation processes.
• Created cleaning validation program for existing and new products utilizing process mapping and learn technologies.
• Created, revised, and managed Laboratory Equipment documentation including User Requirements Standards, Design Qualifications, Trace Matrices, Configuration Specifications and calibration documentation requirements.
• Integrated LIMS with PI Data management services for MDM Project at enterprise level.
• Communicated seamlessly and effectively and in a timely manner with Project Manager, Quality Assurance Validation, QC Technical Services (QCTS), QC Quality Control, Quality Engineering, Method validation team and multiple Catalent sites involved in Laboratory Equipment Qualification and Analytical Methods activities.
• Good understanding of peripheral Lab Informatics Systems like Lab Notebook, Chromatography Data Systems (Total Chrome & NuGenesis) associated with LIMS.
• Validated analytical laboratory equipment’s such as Microplate Reader, GC, HPLC, Atomic Absorption spectrometer, LC/MS(open lab system-CDS), Densitometers, Artel PCS, Face Imager, UV-Visible spectrometer, balance, titrators in compliance with FDA regulations.

Confidential, Fort Worth, TX

LIMS Developer /Business Analyst

Responsibilities:

• Reviewed the previous documentation for each module in the R&DLIMS application, and upgraded to the current template formats.
• Worked on the MS Visio, to draw the workflow diagrams, Process flow diagrams for URS and FRS.
• Maintained and ensured the accuracy of the requirements in URS and FRS by assigning the critical parameters to each of the user and functional requirements.
• Documented User and Functional requirements on individual modules of R&D LIMS such as, Formulation Batch Modules (FBM), Stability Protocol Module (SPM), Integrated Stability Module, LIMS QA Module, Integrated Stability Update Module (ISUM), R&DLIMS Admin Module and Packaging Module (Labeling and Barcode)
• Worked on Labeling System to generate barcodes to the finished products for tracking in Packaging Module.
• Queried on the application to find out the different stability studies and generate various summary reports.
• Participated in many project meetings providing the valuable inputs related to the regulatory requirements such as, Part 11 Electronic Records and Electronic Signature compliance, SOX compliance and importance of documentation, project deliverables, and validation deliverables.
• Worked on reviewing High Level Classification Documentation (HLCD). Helped my teammates to understand the High Level Risk Assessments (HLRA s) Document in conversion into new HLCD s format.
• Initiated the GAP analysis to identify the changes to be included in the current upgrade functionalities from the Control Change Request (CCR) log, Assigned tasks to work on Data Privacy, IT Security knowledge, Test Specifications (IQ, OQ, PQ), Application Design Specifications and Operational Handbook.
• Worked on the determining the custom requirements for e - Learning with LMS for stability studies.
• Worked on MS Project, to update the timelines and to schedule the project deliverables in a timely manner.
• Helped our Project Manager in determining the project risks and calculated the risk occurrence and risk probability.
• Worked with the business to gathered requirements by Barnstorming and one-on-one questioner.
• Co-ordinated with the supervisors and peers about regulatory requirements for the data handling, secure data collection and audit trails.
• Researched and designed the entirely new business process flows and workflow assignments properly assigning them with the other parts of the instruments.
• Worked on documenting the User and Functional requirements (URS and FRS), and addressed the conflicts from the reviewers in project meetings.
• Assigned to work on other project deliverables, such as Equipment Qualification (IQ, OQ, PQ), Application Design Specifications and Operational Handbook.
• Drafted audit trails requirements in the URS and FRS for software for the future purpose.
• Worked on MS VISIO and MS Project to document the project related deliverables.
• Created existing business workflows to examine the areas of improvements in the current flows.
• After observations and analysis, I created To Be workflows, which are more efficient, and automated workflows to make sure the users can perform their day-to-day activities in more user friendly and efficient manner.
• Worked with vendors and business units to felicitate the business process. (Vendor Assessments)
• Conducted requirements gathering sessions and workshops.
• Created compliance deliverables as per the FDA guidance for the GxP applications.

Confidential, Rahway, NJ

Business Analyst/ LIMS Developer

Responsibilities:

• Used MS Project for scheduling and planning project activities.
• Documented and reviewed BRD’S and participated in designing Validation Master Plan (VMP).
• Involved in creating FRS, TRS and other critical system documentation.
• Validated the business, user and functional requirements and segregated them into Use Cases, context diagrams and activity diagrams using Visio, thus defining the Data Process Models.
• Involved in validating SOPs with compliance to CFR Part 11, 210, and 211.
• The governing activities include Authoring Templates for validation related documentation such as validation protocol and plans, IQ, OQ, and PQ.
• Performed test designs, functionality testing, and regression testing on LIMS using HPQC.
• Worked with IT and business teams to drive/maintain/create Quality program and align the design and development methodology with Validation plans, policies and procedures.
• Developed documentation for all aspects of computer system validation including risk assessments.
• Involved in performing GAP Analysis and documented the same to investigate gaps between system operation and the requirements of FDA regulations over the current system.
• Responsible for authoring and reviewing Standard Operating Procedures (SOPs), URS/FRS, DS, Risk Assessment, IQ/OQ/PQ Protocols, Deviation Management, Traceability Matrix and Validation Summary Report.
• Worked as a Packaging Engineer for generating the Serial Numbers and Barcodes in Labeling System for Finished Products and devices for medical use such as diagnostic equipment, surgical devices, ventilators and heart-lung machines.
• Worked extensively with MS Office, MS VISIO, for authoring work flow diagrams in protocols like OQ and PQ. Created Manual Test Scripts and Qualify the Software.
• Acted as Validation Proctor for guiding testers for formal execution of Scripts and provided suggestions on Deviation Reports.
• Worked on LMS (Learning Management Systems) customizing functionality like registration & administration, Event Managements, Curriculum and Management, reporting, record management, and courseware review.
• Extensively performed RISK ANALYSIS by identifying the vulnerability points and recommended disaster avoidance.
• Worked with RTM to track requirements and to co-relate with the executed test cases.

Confidential

Business Analyst

Responsibilities:

• Used UML methodology to define the context diagram and Data Flow Diagrams (DFD)
• Participated in requirement gathering analysis, design development and implementation of the project.
• Developed a Validation Master Plan (VMP) to document the intent of validation effort in accordance with FDA regulations. Involved in Testing Computer Systems using cGxP Guidelines.
• Worked on Agile SDLC during the project phase
• Involved in GAP Analysis for user requirements verification and devised Remediation Plans.
• Developed and maintained documentation for System Development Life Cycle in compliance with the FDA regulations including Test plans SOPs, IQs, OQs, and PQs.
• Maintained and ensured accuracy of document control system. Ensured that all documentation were FDA and GMP compliant.
• Prepared Requirement Traceability Matrices (RTM) and managed every change requests effectively throughout the software development life cycle.
• Executed Operational Qualifications (OQ’s) to make sure that the systems are capable of consistently operating between established limits and tolerances and started an issue log and Deviation Report (DR) if not in accordance.
• Developed test scripts and test cases for automated and regression testing.
• Used HP Quality Center (HP QC) for test script execution.
• Provide technical writing support to the Validation Group as needed.
• Involved with the development team to verify bug fixing and update bug report status.
• Involved in the User Acceptance Testing (UAT) to check the reliability for end users.
• Headed large-scale project to design, configure, and implement new Electronic Document Management System, including data migration and end user and e-Learning LMS Genesis application.
• Worked on LMS (Learning Management Systems) customizing functionality like registration & administration, Event Managements, Curriculum and Management, reporting, record management, and courseware review

Confidential

Business Analyst

Responsibilities:

• Extensively worked with the preparation of Validation Master Plan.
• Conducted individual and group (JAD) sessions with business and technical units.
• Helped in writing Validation Plan in accordance with the Software Requirements Specifications.
• Processed, planned and implemented 21 CFR Part 11 - Electronic Records and Audit Trails.
• Coordinated with the Lead Developer to set up and build the prototype of the application.
• Developed Validation Master Plan and Risk Analysis approach to the Adverse Event Reporting System.
• Prepared SOPs, IQ, OQ, and PQ for the installation, operation and performance of AERS.
• Involved in Test Planning, Test Preparation, Test Execution, Issue Resolution and Report Generation to assure that all aspects of a Project are in Compliance with the Business Requirements.
• Performed GAP Analysis, initiated Remediation Plans and assisted in maintenance of Hybrid Systems.
• Drafted SOPs complying with FDA standards and trained all users on these systems and implications and impact of 21 CFR Part 11 compliant data systems on everyday functions.
• Developed and implemented complete software validation and quality assurance programs including SOPs governing validation activities; templates for validation related documentation such as validation protocols and plans, IQ, OQ, and PQ.
• Involved in Functional Requirements Specifications (FRS) and other critical system documentation.
• Developed Requirement Traceability Matrix (RTM) to track requirements and co-relate with the conducted test cases. Prepared protocols for following cGLP and cGMP procedures.
• Designed Validation of Instrument Systems and ensured compliance with quality system requirements.
• Worked on LMS (Learning Management Systems) customizing functionality like registration & administration, Event Managements, Curriculum and Management, reporting, record management, and courseware review