SUMMARY

• I am currently a Quality Engineer professional with 7 years of experience in health/ Pharma agency (FDA, MHRA etc.) regulated industries with a proven track record managing teams as well as personal experience in the areas of: Computer System Validation, Infrastructure Qualification (including GMP environment), Change Control, Metrics, QMS (Deviations/CAPA, Quality Investigations, Training, Supplier Management) and Auditing.
• Configuration and conducting solution engineer/pre - sales demonstrations & proof of concepts to close new business for EDMS, EQMS and LMS engagements including, Document Management, eCTD, eTMF, Deviation, CAPA, Change Control, Audit and Learning Management Systems.
• Strong Understanding of GxP quality guidelines: Good Manufacturing Practice, Good Laboratory Practice (GLP), Good clinical Practice (GCP), Good Distribution Practice (GDP), and Good Regulatory Practice (GRP).
• Experience in Software Development Life Cycle (SDLC), familiar with Waterfall, V-shape model and agile model.
• Developed Standard Operating Procedures (SOP’s), policies and working instructions to comply with FDA regulations.
• Experience in reviewing and developing User Requirement Specifications (URS) and Functional Requirement Specifications (FRS) in compliance and conformance with FDA rules and regulations.
• Comprehensive knowledge and extensive experience in technical writing of Validation protocols (Installation Qualification - IQ, Operational Qualification - OQ and Performance Qualification - PQ), Validation Master Plan (VMP), SOP’s, Test Summary Report, Test Plans, Test scripts, and Requirement Traceability Matrix (RTM) in FDA regulated environments.
• Good experience in writing Risk Assessment, Remediation Plan, Deviation report, and User Acceptance Testing (UAT).
• Proficient in dealing with Change Control Management System (CCMS), Laboratory Information Management System (LIMS), Enterprise Document Management System (EDMS)
• Experience in reviewing Corrective and Preventive Actions (CAPA) and highlighting and suggesting the remediation plans to mitigate the non-compliance.
• Involved in Data Center Migration Project and responsible for developing the validation deliverables of DataCenter Migration.
• Experience in writing and developing Test Plans, Test Scripts, Test Procedures, and Test Summary Reports of all the laboratory equipment’s.
• Involved in writing the User Acceptance Test Summary Report.
• Used tools like Test Director for submitting testing reports for bug-reporting and bug-tracking.
• Expertise in automated testing tools such as Mercury Quality Center, HP Quality Center and experience in Quick Test Pro (QTP), and Load Runner.
• Supported the conversion of a cosmetic manufacturing facility to a GMP OTC FDA regulated facility.

TECHNICAL SKILLS

Validation skills: IQ/ OQ/ PQ, LIMS, Audit trails, Test Plan, URS, FRS, SOP’s, CAPA, Validation plan, RTM, Compliance Risk Profile.

Operating Systems: Windows 7/2000/2003/XP/Vista, MS-DOS.

Software: HP Quality System, MS Visio

Methodologies: Waterfall, V-Model and Agile

Compliance: FDA Quality system regulations, SOX, 21 CFR Part (11, 50, 58, 110, 210, 211, 600, 820), SOX, Master Control, GxPs (GMP, GLP, GCP).

PROFESSIONAL EXPERIENCE

Confidential, PA

Quality Engineer

Responsibilities:

• Contribute to development and implementation of quality-related training programs for management, field operations and quality associates and track quality assurance metrics.
• Establishes the CAPA Management System and manages its deployment including IQ-OQ-PQ Validation for web-based software tool for the CAPA system. Authored Test Cases, URS and mapping
• Involvement in writing, reviewing and enhancing the validation deliverables (URS, FRS, Design document, IQ, OQ, PQ) for LabWare LIMS
• Manage implementation of BioBook and ActivityBase Electronic Lab Notebook (ELN) products to support the scientists/biologists of the R&D Dept. of Pharmaceutical customers.
• PreparedValidationstrategy plan for implementingeTMF(electronic Trial Master File) Workflows within Documentum EDMS.
• Developed combined Installation / Operational / Performance Qualification (IOPQ) Protocol Amendment and witnessed execution for the Capmatic On-Line Headspace Inspection System Upgrade
• Developed validation test plan, requirement specification and traceability matrix for software applications as required by the business
• Lead Periodic Review program for all the GxP computerized system, authored SOPs and work instruction and provided training and managed QA resources.
• Collaborated with own and third party distribution organizations directed Good Distribution Practice.
• Responsible for internal/ supplier (validation contractors) audits to ensure lab instruments/ equipment and production equipment qualification and computer system validation in compliance with FDA/ICH ISPE GAMP5 guidelines and corporate/ site policy
• Determine the Gamp 5 Software category, business criticality, privacy risk as it relates to 21CFR part 11 compliance and Annex 11.
• Involved in GAP analysis for User requirements and developed Remediation plan to ensure compliance with FDA regulations.
• Implemented cGXP's (GMP, GLP, and GCP) and GAMP 5 guidelines in the systems.
• Configured laboratory information management systems, such as LabVantage SQL LIMS,developing validation master plans and validating LIMS implementations
• Performing Gap Analysis for the different systems like Empower, REES, LIMS, MES and Master Control.
• Remediated for a large drug-compounding company in response to several FDA 483's
• Prepared Standard Operation Procedures (SOP’s) by adhering to cGMP standards and other appropriate regulations.
• Assisted in procedure development and maintenance, quality validation, including capability studies, verification and Gauge R&R, first article reports.
• Documented work process flow, calculated return on investments, performed risk analysis, & alternatives to complete the purchases of an Electronic Lab Notebook(ELN), Chemical Inventory Management System, & Computerized Maintenance Management System.
• Validating, auditing, generating appropriate SOP’s, executing protocols, developing specifications, risk management / assessment, and maintaining traceability for large scale systems/software including PLC’s, MES, SDS, CDS, SDMS, and PLM.
• Developed test scenarios for testing workflow paths in TrackWise.
• Develop and execute Installation, Operational and Performance Qualification Protocols for Electronic Batch Management following SDLC, cGMP, FDA 21 CFR Part 600 regulations, ISO, GAMP 5 guidelines and company policies.
• Responsible quarterly / semi-annual SOX 404 compliance, control, audits, and risk management
• Developed and maintained Requirement Traceability Matrix (RTM) to cross-reference the functionality to the required verification and validation documents.
• Prepares SOP's for Good Distribution Practice and ensures compliance thereof.
• Provide recommendations on LabWare LIMS processes while focusing on industry best practices and commercial off the shelf functionality
• Responsible for assisting in the implementation of software systems in compliance with regulatory requirements as they pertain to 21 CFR Part 11 and GAMP 5.0 standards.
• Reviewed test cases and scripts and documented the results as per the FDA regulations.
• Developed Test Summary Report (TSR) based on the execution of test scripts.
• Worked with data center technical support and updated Infrastructure Design and Configuration Documents for SQL Cluster and Data Center move projects.
• Interfacing, qualifying and validating (cGxP) instruments and network systems in the laboratory and manufacturing environment to an Electronic Laboratory Notebook system.
• Authoring of Validation Documents for release of TrackWise system into production using CSV and SDLC methodologies.
• Performed ISO 13485 Quality System review and ISO 14971 Risk Management audit review of medical devices, IAW 21 CFR 820

Confidential

Quality Assurance Inspector

Responsibilities:

• Quality Assurance Inspector required to inspect all completed work to ensure completion is built within standards and that all safety requirements have been met in accordance with applicable directives.
• Involved in drafting and approval of URS for Laboratory equipments.
• Advised and evaluated product verification/validation activities and identified corrective actions.
• Designed Performance Qualification forLabVantageLIMSby studying the business rules and interviewing the users.
• Analyzed and reviewed validation deliverables like Validation Plan, Risk Assessment, Validation Summary Report in compliance with 21 CFR Part 11, GAMP 5 and GMP FDA Compliance
• Involved in Risk Assessment of laboratory instruments.
• Reviewed & released analysts' test results for cGMP & FDA compliance. Investigated anomalous & OOS results.
• Provide expert recommendations and decisions on regulatory issues relating to CMC and coordinate authoring and review of content, including proactive risk management and mitigation.
• Responsible for creating the Corrective and Preventive Action Plan (CAPA) and performed the GAP analysis to remediate audit findings and observations given by the auditors for regulated Research and Development (R&D) applications
• Build and support LabWare LIMS specific processes like batch/lot creation, quality disposition, and sample chain of custody
• Validated pharmaceutical computer systems and manufacturing facilities at client site following GAMP, FDA, GMP, and 21 CFR Part 11 regulations.
• Prepared validation plan (VP) for validating analytical laboratory equipment and also Labware LIMS integration with ELN.
• Analyzed and directed orders for initiation of Risk Assessments related to Cleaning Validation/Verification projects.
• Validated computerized laboratory equipment based on GAMP 4.
• Performed remediation and validation of legacy and new computer systems - GLP and GMP assessments, GAP assessments, writing validation plans, user requirements, functional specifications, IQ, OQ, PQ and summary reports.
• Provide regulatory guidance to internal business to comply with cGxP/SOX. eClinicalOS Study Designer with Inventory/Dispense Certified in compliance with SOP, cGxP, cGCP, cGLP, cGMP (21 CFR Part 11, Annex).
• Involved in reviewing the validation protocols for theLabVantageLIMSapplication and understanding the entire Validation SDLC pertaining to the project.
• Documented Test Procedures for various modules (Security, Environmental Monitoring, Stability, Calculations, Standards and Reagents) for LabWare LIMS.
• Involved in preparation of documents for Computer systems validation documents in accordance to 21CFR Part 11.
• Implemented and managed Functional design requirements, design input and output (I/O), design Verification and Validation (V&V) and design risk management.
• Worked in compliance with FDA regulations and cGxP guidelines in all the aspects of Computer Systems Validation.

Confidential 

Software Quality Validation Engineer

Responsibilities:

• Responsible for providing Software Quality Assurance (SQA) engineering support for all lifecycle phases of computerized systems that include MES, TRS and PDM
• Ensuring that the company’s Quality Standards and Procedures for Computerized Systems, as defined in Boston Scientific’s Quality Management System are enforced
• Follow departmental and company-wide SOPs, policies and procedures for software quality assurance directly contributing to quality deliverables
• Responsible for generating and reviewing CSV deliverables in compliance with 21CFR Part 11 and GxP FDA Compliance Regulations.
• Participate in the validation of Computerized Systems such as, but not limited to, Enterprise Software, Medical Device Test Fixtures, and R&D lab equipment’s
• Review of GMP documentation for compliance
• Communication with the LIMS team, researchers and end users to maximize resource usage
• Review tools for LIMS decision support to be used by the site. Analysis of LIMS enhancements, troubleshooting issues, second tier application support and routine master data configuration as required within the LabWare LIMS application.
• Responsible for performing advanced journeyman-level calibrations, diagnostics, troubleshooting, repairs, and modifications for industrial process control instruments in a cGMP/cGXP environment.
• Ensuring that the clinical and medical device documents are in compliance with cGMP and GLP guidelines.
• Initiating CDP, machine procurement, Master validation, IQ/OQ/PQ Protocol writing, DOE to find out optimum parameter, machine installation and validation to prove the process capabilities and summary writing for manufacturing release
• Defined and implemented risk based validation strategy for various GxP applications for effective and efficient implementation according to applicable internal and external regulations.
• Wrote and reviewed the system related SOPs to ensure compliance of company’s processes, policies, and procedures.
• Validation Engineer for Computer System Validation at a cGMP site
• Managed and served as liaison between for business teams and vendors and quality assurance supporting validation activities
• Perform timely data review with a high focus on data quality to ensure accuracy, completeness, cGMP compliance, and neatness of analytical documentation
• Performed reviews for data accuracy of excel spreadsheets for validated systems
• Oversaw the execution of the tests and reported status to the QA Manager.
• Involved in reviewing Design history files and key design activities including Design plans, Design changes and Final design outputs
• Participated in quality improvement initiatives and actively apply software QA methodology standards
• Create, maintain, summarize, review and approve QA related-documentation against quality-document attributes, including but not limited to GDP, completeness, traceability, accuracy, coverage and testability of system requirements, software defect detection, compliance risk mitigation, change management
• Interacted with Product and project management teams on system-related enhancements as well as issue resolutions and assisted in audit activities as part of the audit readiness team
• Lead Periodic Review program for all the GxP computerized system, authored SOPs and work instruction and provided training and managed QA resources.
• Requested master batch records and reviewed batch records for cGMP documentation practices at completion of each batch run.
• Performed a QC check on the validation deliverables before submitting to document control