- Around 12 years of professional experience in IT industry with specialization in the areas of Computer Systems Validation and profound knowledge of FDA 21 CFR Part 11 Rules and Predicates.
- Strong experience in developing & executing protocols. Experience includes Validation Master Plans, IQ, OQ, PQ Protocols and Validation Summary Reports.
- Strong experience in implementing Good Documentation Practices(GDP) in writing and reviewing validation deliverables.
- Experience in validation of Application Servers, Disaster Recovery systems, Back Up Servers and Controlled Spread sheets.
- Hands on experience in Technical Writing, implementing QA Audits /Methodologies, Test Plans, Test cases and Test documentation.
- Good understanding & implementation knowledge of cGxPs (GMP, GCP, GLP).
- Hands on experience in the validation of Custom Application and Business Systems (CABS) like Laboratory Information Management System (LIMS), Clinical Trial Management System (CTMS), Plateau Learning Management System(LMS), Remedy and Trackwise.
- Hands on experience in validating automated systems in pharmaceutical companies by implementing Good Automated Manufacturing Practices(GAMP).
- Good working knowledge of Quality Management Systems(QMS) like Remedy and Trackwise.
- Experienced in all the stages of the SDLC (Software Development Life Cycle) & VLC (Validation Life Cycle).
- Good understanding & implementation knowledge of Good Testing Practices(GTP).
- Experience in performing GUI, White Box/Black box (Unit & Functionality), System & Integration, Regression, Performance & UAT (User Acceptance Testing) testing.
- Good experience in using testing tools like HPALM, Quality Center, QTP and in designing and development of queries using SQL.
- Good knowledge of Industry standards like ISO 9000.
- Strong analytical, presentation and communication skills with quick assessment & problem solving approach.
- Diligent worker, self - starter and consistent performer, adaptable to work as a team member as well as independently.
FDA Regulations /Validation Protocols: 21CFR Part 11, 210/ 211, 810, 820, cGxPs (cGMP, cGCP, cGLP), URS, FRS, RTM, IQ, OQ, PQ, SOPs, VSRs
Clinical Applications: Labware*LIMS, Clinical 4.0, Clinical Trial Management System(CTMS).
Operating Systems: Windows 95/98/2000/NT/XP, Hp-Ux, VMS/VAX, UNIX, MS-DOS, Solaris 9/10, Pentium Systems, Citrix Metaframe Tools, IBM Compatible PC’s.
Networking: TCP/IP Protocol, Citrix, Tibco interfacing, ISP routing
RDBMS: Oracle 8i/9i/10g, DB2ver6.0, SQL Server v 6.5/7.0/7.5/2 k, MS-Access
Testing Tools: HP ALM, QTP
DataWarehousing Tools: Informatica, Cognos Enterprise Planning and Teradata
Packages: EDMS, Documentum4i, Lotus Notes, Track wise, Remedy, Spotfire, Business Objects, MS Office, MS Project 2000, MS Visio, Crystal Reports 6.0/7.0/9.0.
Business Analyst/Validation Manager
- Gathered requirements from chemists, analysts and manufacturing support personnel for the quality systems.
- Elicited requirements using workshops, interviews, site visits and conference calls to gather the requirements.
- Identified business workflows on how Deviations, CAPA s and Change Controls are created and managed during pharmaceutical production and analysis.
- Created User Requirement Specifications from the gathered requirements, review with the business teams and finalize the requirements.
- Created Functional Requirement Specifications for the quality systems.
- Identified the Good Manufacturing Practices (GMP) and 21 CFR Part 11 regulations that are applicable to the quality systems.
- Created Validation Plan to identify the validation efforts that will be followed and implemented throughout the project.
- Reviewed Installation Qualification/Operational Qualification/Performance Qualification scripts to test the quality systems that are developed based on the User Specifications and Functional Specifications.
- Coordinated with the Quality Systems business owners to identify the scenarios that will be tested for User Acceptance Testing.
- Ensured that all defined business requirements and compliance requirements are implemented in the systems as intended.
- Created templates in Master Control system to load Cleaning Validation SOPs into different info card types like cleaning matrix, dirty hold times, Clean in Place (CIP) and Steam in place (SIP) procedures.
- Acted as a liaison between business owners and technical teams to coordinate the efforts of implementing the quality systems.
- Identified the gaps in the systems and requirements and work with business teams and technical teams to close the gaps.
- Provided business solutions and technical solutions where ever applicable.
- Managed and tracked the progress of implementation of quality systems.
- Reviewed and updated functionality whenever and wherever required to enhance the performance of the system and to meet the user’s requirements.
- Ensured that the changes are implemented thru change control process and the systems are maintained in a validated status.
Environment: Stratas (Sparta cloud version of Trackwise) QM 4.2, Master Control, Oracle 12R, HPALM, Mainstar, Metasays
- Created Change Controls for the implementation of enhancements to the Events and CAPA workflows.
- Resolved support tickets related to TrackWise and Pharma Data Portal.
- Loaded master data for different workflows in TrackWise.
- Revised User Requirement Specifications and Functional Requirement Specifications of EVMGT workflows and PQMS.
- Created User Requirement Specifications and Functional Requirement Specifications for Change Control workflow in TrackWise.
- Created workflow in Trackwise to create and manage events from process validation.
- Created User Requirement Specifications and Functional Requirement Specifications for Pharma Data Portal System.
- Performed Risk Analysis on Pharma Data Portal system to identify the business and compliance classification of the system.
- Created Compliance Plan, Validation protocols, IQ/OQ/PQ test scripts, Validation Summary Report and Compliance Report for TrackWise, PQMS and Pharma Data Portal systems.
- Worked closely with business users to prepare the data scenarios for the User Acceptance Test of Pharma Data Portal.
- Performed dry runs on TrackWise and Pharma Data Portal systems and communicated the defects with the technical teams.
- Reviewed the ETL documents of the Enterprise Data Warehouse.
- Validated the views in the Source Systems from which the data from the source systems is extracted into Data Warehouse.
- Validated Pharma Data Portal against security and compliance requirements to ensure that the system meets the security and compliance requirements.
Environment: Trackwise 8.3, PQMS, Oracle 11g, Quality Center 11.0, TeraData, Spotfire,MS Visio.
- Followed CSV and SDLC methodologies to validate Trackwise application.
- Developed validation documents like Validation Plan, Validation Summary Reports, IQ/OQ/PQ test scripts, Traceability Matrices etc..
- Developed and executed automation scripts using QTP .
- Managed the testing process, schedule batch tests, log and track defects using Quality center.
- Responsible for creating the test cases in Quality center and mapping them with the requirements.
- Created System Design Specification (SDS), Functional Requirement Specification and User Requirement Specification documents.
- Created System and UAT Test scripts to support validation of system upgrade and enhancements.
- Configured TrackWise and developed custom Crystal XI reports for CAPA, Complaint management, Ship Hold and Change Control projects.
- Created numerous Crystal Report templates for data trending and periodic reports.
- Modified the existing Crystal Reports as per the changed business requirements.
- Developed traceability matrices to ensure all the requirements are identified and tested.
- Ensured that the Trackwise application is in compliance with 21 CFR Part 11 regulations, GxP and Confidential SOP.
Environment: Trackwise 7.0, Oracle 10g, Plateau 5.8, Apache, SAP CRM 4.0, SAP BI 6.0, QTP 9.0, Quality Center 9.0, MS Visio.
Validation Specialist Consultant
- Reviewed and edited the URS/FRS/DS documents of the laboratory equipment(HPLC, GCMS and LCMS) and LIMS application.
- Developed Validation plan to validate the laboratory equipment and LIMS application.
- Developed IQ/OQ/PQ test plans, traceability matrices, deviation forms and validation summary reports.
- Developed and executed IQ/OQ/PQ test plans and test scripts.
- Reviewed the edited URS/FRS/DS documents as per the change request.
- Involved in periodic auditing of the change management systems to ensure that the change management systems are in compliance with Forest Labs change management SOP.
- Involved in performing maintenance validation of autoclaves, fermentation chambers and mixers.
- Managed and organized all the quality assurance and related documents in documentum.
- Experience in automating Corrective Action and Preventive Action (TrackWise) processes in FDA and ISO regulated environments.
- Used various functionalities in Business objects like prompts, slice & dice, drill through, using breaks to fold and unfold data for summary and detail reports, pictorial representation of data using various graphs for data mining.
- Uploaded analitycal specs and test methods in LIMS and mapped to various processes like swabbing techniques, sterility testing and method limitations.
- Analyzing the Data models, Data Schema, ETL procedures, SQL queries to perform back-end testing.
- Created data warehouse test environment to test the mappings and effectively coordinated the migration between QA, Dev and Production environments.
- Involved in the Change Advisory Board(CAB) meetings to discuss the GxP/PDMA impact of new change requests and the compliance risk level associated with the change.
- Involved in the discussions with business and IT managers on the status of open change controls.
- Involved in designing Automation Framework for AUT Using QTP.
- Involved in analyzing the functionality of the AUT and designed the common function libraries which can be reused during automation using QTP.
- Reviewed and approved the test execution scripts in Quality Center.
- Managed the testing process in Quality Center as per the Forest Labs SOP.
- Ensured that LIMS application is in compliance with 21 CFR Part 11 and cGxP regulations.
- Ensured that all the change controls are in compliance with GxP/PDMA regulations before they are closed out.
Environment: Labware LIMS, HPLC, GCMS, Business Objects Xi r2, Plateau 5.8, LCMS,Crystal Reports 11, Solaris 10, SAP CRM 4.0, SAP BI 6.0, JRE, Apache, Siperian, Oracle 9i, Documentum, TrackWise 7.0, Remedy 7.1, Quality center 9.0, QTP 9.0.
Validation Specialist Consultant
- Involved in developing & documenting the URS, FRS & DS documents.
- Worked on developing Network design to increase the performance of the LIMS client over various sites.
- Involved in writing the computer system validation Risk Assessment documents, Validation Plan, Test Summary Reports and Validation Summary Reports.
- Involved in writing, reviewing & editing the IQ, OQ, & PQ test plans & test scripts.
- Wrote test cases in Test Director and ensured that there is a perfect mapping from the requirements tree to the corresponding test cases tree in Test Director and prepared Traceability Matrices for this purpose.
- Worked on MS Visio to create business and technical diagrams that document and organize complex ideas, work flow and processes for the LIMS and other applications.
- Used Citrix Metaframe Xpe FR2 to connect to Oracle for reporting purposes and to generate audit trail reports.
- Performed regression testing using QTP.
- Worked in the design and development of queries using SQL, PL/SQL.
- Performed formal testing and ensured that specific requirements of 21 CFR Part 11 are covered.
Environment: Labware LIMS, Oracle 8i, Apache, Test Director 7.0i, MS Word, MS Visio.
- Reviewed and edited Validation Master Plan (VMP), which is relevant to the components involved in maintenance of electronic documents in accordance with 21 CFR PART 11 regulations.
- Developed URS/FRS/DS documents and IQ,OQ, PQ protocols.
- Coordinated with system analyst and network administrator to make the server, machines and network qualified through complete Installation Qualification (IQ) and Operational Qualification (OQ) procedures.
- Involved in performing and documenting GAP analysis and Risk Assessment.
- Analyzed the requirements and critical areas of the application to setup and execute baseline tests.
- Drafted SOP’s and trained all users on these systems and the implications and impact of 21CFR part 11 compliant data systems on day-to-day functions.
- Involved in the analysis of security and audit trial features with Excel Spread sheets.
- Involved with investigative site on issues concerning current clinical trials.
- Performed load testing to test the proper working of IP addresses and TCP/IP protocols using Load Runner.
- Person responsible to ensure that the clinical trial management system is in compliance with 21 CFR PART 11 regulations, cGCP regulations and Confidential SOPs.
Environment: Siebel Clinical, Oracle 8i, Labware*LIMS, WinRunner 6.5, Test Director 5.0, Load Runner 6.5, HTML, PL/SQL, 21CFR Part11, Windows NT, MS Excel and Word.