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Technical Writer Resume Profile

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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.

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