Technical Writer Resume Profile
Plantation, FL
Summary of Qualifications:
- Excellent experience as a Validation Project Manager / Validation Analyst/ Quality analyst
- More than Six years of diverse experience in Information Technology with emphasis in Verification, Validation, 21 CFR Part 11 and Quality Assurance.
- Developed and analyzed Test Plans and Test Scripts to check the functionalities of the application for 21CFR part 11 compliance and FDA Regulations, GAMP, cGMP, cGLP, and cGCP.
- Expertise in technical writing and reviewing of Validation Protocols IQ, OQ, PQ , performing Gap Analysis and developing Remediation Plans.
- Involved in conducting Manual Testing and Automated Testing of the Software Application.
- Excellent experience of Records Manager Administrator and Documentum.
- Experience in Validation of SAP GUI.
- Experience in validation of Laboratory Information Management System LIMS .
- Good understanding of SQL Queries.
AREA OF EXPERTISE:
- Developed and analyzed Test Plans and Test Scripts to check the functionalities of the application for 21CFR part 11 compliance and FDA Regulations, GAMP, cGMP, cGLP, and cGCP.
- Expertise in technical writing and reviewing of Validation Protocols IQ, OQ, PQ , performing Gap Analysis and developing Remediation Plans.
- Working Knowledge of 21CFR part 11, 99, 201, 202 and 203.
- Experienced in preparing Quality Assurance Audits and Reviews
- Experience in performing Gap Analysis, reviewing and performing Corrective and Preventive Actions CAPA and suggesting the Remediation Plans to mitigate the non-compliance.
- Developed Standard Operating Procedures SOPs and trained users on SOPs for many analytical instruments and manufacturing methodologies.
- Proficient in dealing with Laboratory Information Management System LIMS on platforms like Quality Control Sample Management , Process, and Instrument Connect, Adverse Event Reporting System AERS , Quality Center QC , Change Control Management System CCMS and Electronic Data Management System EDMS .
- Also proficient using Documentum and Trackwise softwares.
- Experienced in collection of User Requirements and Functional Requirements.
- Well acquainted with all phases of Software Development Life Cycle SDLC methodologies like Agile, Waterfall, V model and Spiral.
- Excellent knowledge of SQL queries.
- Experience in writing and executing user acceptance tests UAT .
- Experienced in working with validation team to develop the validation plan and test cases.
- Maintained favorable relationships with peers and seniors at all levels of the organization
- Solid written, communication and presentation skills able to negotiate well, and resolving business issues.
- Adaptable, flexible, and thrive in working in a challenging environment.
- Effective team leader that is goal-driven and has exceptional interpersonal skills.
TECHNICAL COMPETENCIES:
Validation: 21 CFR PART 11, PART 210, PART 211, cGMP, cGDP, cGLP, cGCP, GAMP, IQ, OQ, PQ, URS and SOPs, RTM, Audit Trails, SDLC, TSR and VSR.
Application: SQL- LIMS, AERS, Argus, Trackwise and Documentum.
Operating Systems: Windows 2000/ 2003/ XP/ Vista/7.
Office Tools: MS Word, MS Excel, MS PowerPoint, MS Access.
Testing Tools: HP-Quality Center.
Programming Languages: SQL.
Laboratory Equipment: Agilent Chemstation HPLC/GC , Waters Empower HPLC , UV-VIS, Incubators, Centrifuges, Sonicators, Autoclaves and Stability Chambers.
Work Summary
Confidential
Technical Writer
Responsibilities:
- Involved in preparing Validation Master Plan VMP and test plan.
- Developed Technical Documentation such as technical manuals, data flow diagrams, requirement documents etc.
- Developed FDA and GMP compliance documentation
- Developed Process/Procedures SOP-Standard Operating Procedures standards documentation
- Developed Installation guides and Release Notes for the Released Application
- Conducted Software/documentation usability tests
- Performed and implemented technical and peer reviews of product documentation
- Coordinates, assigns, tracks, and assesses multiple documentation projects
- Was involved in documentation during various stages of the AERS validation lifecycle, in accordance with FDA regulations, including 21CFR Part 11.
- Provides status updates on projects as required by management
- Worked closely with users and the vendor to understand and document user requirements, and functional design specifications.
- Developed and implemented validation and quality assurance programs including Standard Operating Procedure SOPs governing validation activities templates for validation related documentation such as validation protocol and plans, Installation Qualification IQ , Operation Qualification OQ , Performance Qualification PQ
- Provided QA oversight to the developers and facilitated the development and implementation to meet the requirements of 21CFR Part 11.
- Involved in updating the Testing Methodology for the QA department and generating various documents to provide uniformity in the execution and reporting of tests.
- Participated in documentation of the Validation Summary Report.
- Actively participated in Project meeting and reviews.
Confidential
Validation Analyst / Technical Writer
Responsibilities:
- Assisted in creating the Validation Master Plan and Test Plan.
- Involved in requirements gathering sessions with manufacturing division to determine and create the Functional Requirements Specification FRS .
- Created Test Scripts Operational Qualification to test the functionality of User Specified Customizations and Oracle Reports run through SQL LIMS v5.0.
- Performed unit testing of PL/SQL code to ensure the functionality of customizations was met.
- Assisted and documented Installation Qualification the data migration process to upgrade the Oracle database from 8i to 10g for development and validation environment.
- Coordinated with the Quality Assurance department to ensure all test scripts run successfully in Validation Environment.
- Performed backend testing SQL queries to validate reports generated.
- Executed Gap Analysis to ensure 21 CFR Part 11 was implemented.
- Involved in developing and testing Interface of LIMS with various pharmaceutical laboratory equipment's
- Assisted in maintaining the Requirement Traceability Matrix.
- Worked with Quality Assurance team and initiated UAT
- Handled and published regulatory documents in Documentum
- Generated deviation reports and change control requests to resolve deviations.
- Generated, tracked, and maintained change control procedures and change management as and when necessary.
Confidential
Validation Engineer
Responsibilities:
- Worked on Validation of Legacy Systems in compliance with 21 CFR Part 11.
- Involved in drafting and approval of URS for all kinds of Medical Equipments as a part of legacy conversion.
- Complete 21 CFR Part 11 compliance assessments of Medical Systems
- Created and documented the Change Order Forms and routed for approval.
- Hands on experience in writing Requirement Traceability Matrix, SOP's, and Validation Summary Report.
- Maintained batch records to check the inventory tracking.
- Responsible for Application Inventory Management and periodic review of the application logs.
- Performed User Acceptance Testing to check the various functionalities of LIMS.
- Involved in writing and executing Test Cases and Test Scripts to validatecertain functionalities of LIMS
- Involved in documenting and evaluating of Test Scripts for legacy conversionof equipments.
- Assisted in generating the Error Report Form and resolving the errors encountered during the testing effort and maintained the Error logs for the errors.
- Maintained the Requirements Traceability Matrix RTM .
- Conducted GAP Analysis and prepared Remediation Plan
Confidential
QualityAnalyst
Responsibilities:
- Reviewed 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 reviewed Functional Requirements Specifications FRS for LIMS sample module.
- 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 .
- Updated System Design Specification SDS document and validated audit trails for events time stamping requirements.
- Created and maintained Requirements Traceability Matrix RTM to track user and functional requirements
- Created Test Plans and uploaded in Quality Center, executed and validated Test cases, validated the Test Reports generated by the LIMS application for compliance with 21 CFR part 11 requirements.
- Wrote Working Instructions for different users of the application and assisted in drafting the Standard Operating Procedures SOP .
- Reviewed versions of Data Migration document and prepared a Data Migration Summary document.
- Performed Gap Analysis and Remediation procedures for LIMS modules that helped in preventing bugs.
- Responsible for CAPA management and corresponding change control procedures.
- Performed ERES risk assessment for electronic records and electronic signatures to assess 21 CFR Part 11 applicability and compliance.
- Used Quality Center for bug tracking and reporting, also followed up with development team to verify bug fixes, and update bug status.