SUMMARY

• Diversified experience as a Validation professional in the pharmaceutical industry, known for the ability to develop and implement processes that positively impact the compliance results.
• 5 years of experience as a Validation Analyst/ Technical Writer in pharmaceutical industry with concentration in Computer System Validation (CSV) and 2 year of experience in Method and Process validation.
• Strong understanding of 21 CFR Part 11 drug GXP requirements including electronic records, electronic signatures, system validation strategies and documentation.
• Working experience in FDA regulated environment and research laboratories with good understanding of cGxP (cGMP, cGDP, cGLP) standards and Risk based validation.
• Experience in generation of status reports and metrics using the integrated TrackWise system along with crystal reports and their development.
• Configured changes including updates to global change control process.
• Competent in quality system and standard 21 CFR (part 11, 50, 58, 210, 211) and GAP Analysis.
• Good knowledge of Software Development Life Cycle (SDLC), familiar with Software Methodologies like Waterfall, Spiral, V - Model and Agile in relation to development and testing.
• Experience in reviewing and developing User Requirement Specifications (URS), Functional Requirement Specifications (FRS) and Design Specifications (DS) in compliance and conformance with FDA rules and regulation.
• Expertise in developing the validation protocols, executing tests, and construction of summary reports for IQs, OQs and PQs.
• Experienced in drafting new SOPs & training users on SOPs for various systems.
• Expertise in preparing Risk Assessment, Remediation Plan and Deviation Reports for FDA regulated environment.
• Sound knowledge of clinical trial processes and clinical data management practices.
• Experience in reviewing Corrective and Preventive Actions (CAPA) and highlighting and suggesting the remediation plans to mitigate the non compliance.
• Developed comprehensive Test Plans, Test scripts, Test Case and Test Reports. Performed Regression, Black box, System and UAT testing using both HP Quality Center and paper based manual testing.
• Proficient in dealing with Change control management systems, Laboratory information management system (LIMS), Adverse event reporting system (Argus safety AERS), Enterprise document management system (EDMS).
• Hands on experience in tools like HP Quality Center, TRIM Context Dataset, Documentum eRoom and DOORS.
• Good experience with MS Visio in developing flow charts and flow diagrams.
• Knowledge in handling various analytical instruments like HPLC, TLC, LC, GC column chromatography, UV-Visible Spectrophotometers, flame photometer and FTIR.
• Excellent communication, writing and interpersonal skills and strong ability to perform as part individually and also as a part of team.

TECHNICAL SKILLS

Operating System: Windows2000/2003/XP/Vista, MS-DOS

Tools: MS Visio, MS Project, MS Office (Word, Excel, PowerPoint, Access), Documentum, Mercury Win Runner/ Load Runner/ Quick Test Pro and HP Quality Center.

Bug Tracking and Reporting: Mercury Test Director, PVCS tracker, Rational Requisite Pro

Regulations: FDA Quality system regulations, 21 CFR (part 11, 50, 58, 210, 211), GxPs, IQ/ OQ/ PQ, LIMS, AERS, Audit trails.

PROFESSIONAL EXPERIENCE

Confidential, CO

Sr. Validation Engineer/Technical writer

Responsibilities:

• Responsible for assisting in the implementation of software systems in conformance with regulatory requirements as they pertain to 21CFR part 11.
• Provided TrackWise implementation consultation and conduct Functional and Technical review sessions when ever needed.
• Resolved Configuration and Testing issues during and after implementation of TrackWise system.
• Experience in TrackWise environment tuning and optimization processes.
• Experience in migrator utility, snapshots, exports/imports.
• Reviewed and modified existing Standard Operating Systems (SOPs) for Document management system, System Administration, Change Control Procedures and Testing SOPs.
• Designed, configured, tested and documented trackwise application, translated the user requirements into data, workflow and logical processing design requirements.
• Responsible for analysis, maintenance and administration of process management systems and quality management solutions environment.
• Communicated risk and compliance issues regarding PKS validation.
• Conducted meetings with the team members to point out the deficiencies in requirements and suggested the ways to cover it.
• Made changes to the system seamlessly using point and click configuration tools in TrackWise system.
• Authored and reviewed the following types of documents: User/ Functional Requirements, Technical Design Specifications, Validation protocols (IQ, OQ, PQ) and validation final reports.
• Maintained interfaces between TrackWise and other systems.
• Conducted workshops to validate the configuration design and explore TrackWise gap resolution options based on industry best practices and business process reengineering and streamlining.
• Responsible for coordinating with team members in locating, tracking, organizing and verifying validation documentation for cGMP compliance and regulatory requirements.
• Reviewed the User Requirements and prepared the detailed Test Plans and Test Criteria.
• Developed, reviewed and executed Test Plans, Test Cases and Test conditions
• Designed and wrote training manual templates and was involved in project planning.
• Generated and submitted the weekly status reports.

Confidential, Pittsboro, NC

Validation Analyst/ Tester

Responsibilities:

• Designed, implemented and validated 21 CFR Part 11 compliance strategies for LIMS.
• Installed TrackWise system and its components in all applicable servers for implementation.
• Good in team work, able to meet deadlines and handled changing priorities in the work flow.
• Ability to troubleshoot TrackWise environment level issue using Oracle and TrackWise configuration parameters
• Played a major role in performing part 11 assessment, especially contributing to the components involved in the maintenance of Electronic Records (ER), Electronic Signatures (ES) and Audit Trails in accordance with 21 CFR part 11 regulations.
• Provided system support and configuration support required to maintain quality management solution.
• Wrote the technical specifications for new business processes, updated technical specs for improvement and generated validation documentation.
• Authored and reviewed the procedures pertaining to Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification protocols for the LIMS application.
• Analyzed User and Functional requirements to develop Test Plans, Test Cases and Test Scripts using HP quality center and executed them. Executed validation test cases based upon system requirement and FDA standards.
• Performed functionality testing for the entire application. Responsible for weekly status reports, updated showing the progress of Manual Testing effort and open issues to be resolved.
• Developed test cases and test scripts to perform regression testing. Tracked and closed the defects using HP Quality Center.
• Responsible for performing User Acceptance Testing (UAT) for the application.
• Maintained the Requirement Traceability Matrix (RTM).
• Involved in reviewing Corrective Action and Preventive Action (CAPA) and drafting Remediation plans for the project management approval after GAP analysis.
• Involved in writing the Computer System Validation Risk Assessment documents, Test Summary Documents and Validation Summary Report (VSR) to summarize overall validation activities.

Confidential, Annandale, NJ

Software validation Quality Assurance Analyst

Responsibilities:

• Worked on AERS to capture all clinical trials.
• Implement Trackwise in conjunction with 21 CFR Part 11.
• Involved in generation of crystal reports and development of crystal reports.
• Involved in internal mock audit by quality organization.
• Responsible for generating and reviewing CSV deliverables in compliance with 21CFR Part 11 and GxP FDA Compliance Regulations.
• Documented the Vendor Assessment Report.
• Developed Design Specifications (DS) document. Used MS Visio for pictorial representation of the Design Specifications.
• Responsible for writing training manual and SOPs.
• Sharing knowledge for promoting best practices to be followed by project teams.
• Responsible for documenting IQ/OQ/PQ protocols.
• Created Requirements Traceability Matrix (RTM) to track the User and Functional Requirements.
• Developed test plans and test scripts for validation testing.
• Responsible for developing protocols for audit trail, time stamp and electronic signature for workflow of documents.
• Developed the Validation Summary Report.

Confidential, San Francisco, CA

Validation Analyst/Tester

Responsibilities:

• Reviewed and modified existing Standard Operating Systems (SOPs) for Document management system, System Administration, Change Control Procedures and Testing SOPs.
• Responsible for analyzing and reviewing validation deliverables like Validation Plan, User Requirement specification, Functional requirement Specification, System Design Specification document.
• Involved in internal mock audit by quality organization.
• Worked on change control documentation such as Change Request Form (CRF’s), Change Control Implementation Plan, Change Control Summary Report.
• Responsible for writing test plans, test scripts and executing them for validation testing.
• Reviewed and verified test results, identified and reported issues and provided summary test reports.
• Documented Installation Qualification (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ) documents using standard templates.
• Authored and reviewed Requirement Traceability Matrix (RTM).
• Developed applicable test cases for integration test, system test and acceptance test. Defects were tracked while processing testing and reported using Test Director.
• Expert level knowledge in reviewing and modifying standard operating procedures (SOP).

Confidential

Technical Writer

Responsibilities:

• Designed, developed, tested and implemented EMBRs (Electronic Master Batch Records), in accordance with company’s Quality Systems, FDA compliance, and other regulatory standards.
• Lead the analysis of the Batch Record requirements and developed EMBRs, design documents and test scripts in accordance with SOPs (Standard Operating Procedures) and SME (Subject Matter Experts) input.
• Developed the design process including gap analysis, design document creation, and prototype development to support design reviews.
• Created and maintained EMBRs associated test scripts and submitted change controls while meeting and reporting on development deadlines.
• Acted as liaison between Manufacturing, QA and QC in responding to commitments and change control items concerning SOPs and EMBRs.
• Ensured the final EMBR meets the department business requirements and is reviewed by Shop Floor Personnel, Production Management, Technology, Safety and QA.
• Trained end users in batch record execution.
• Developed and revised SOPs, using document management tool to control review and approval cycles.

Confidential

Process Validation Engineer

Responsibilities:

• Developed validation protocols and generated amendments to the protocols as required
• Documented deviations that occurred during the protocol execution.
• Verified the calibration and maintenance status of the equipment.
• Scheduled validation activities and trained production operators.
• Monitored critical steps in the manufacturing process.
• Assured that approved testing standards are being used.
• Provided operational oversight to ensure the experimental execution and process technology transfers are delivered with right first time quality.
• Developed reports, batch records, procedures, risk assessments and project schedules to ensure successful project execution.
• Applied principles of cGMP, GAMP as related to process design.
• Trouble shoot equipment problems, identified the need for new equipment and made modifications to the existing equipment to optimize throughput and reduce process cycle time.
• Evaluated all the test results and generated a validation report.