SUMMARY

• Experience as a Validation Engineer, GMP Compliance and Quality Engineer in diversified industry sectors including Pharmaceutical/Bio - Pharmaceutical, Manufacturing and Medical device.
• Proficient in Validations, Quality, Regulatory Compliance, Commissioning, Qualification, FDA regulation, cGMPs, GxP and CV.
• Expertise in Computer Systems Validation (CSV) SDLC, and Quality Assurance as per FDA regulations including working knowledge of the FDA predicates (specifically 21CFR Part 11/203/210/211/820 ), GMP, GLP, GCP,GDP and GAMP.
• Expert at QSR's, ISO 13485, ISO 14971, 21 CFR 11, Annex 11,GAMP, SDLC methodologies, and ITIL and validation of ERP SAP.
• Familiarity with software lifecycle in a regulated environment (ISO9000/FDA).
• Execute validation protocols as needed (Equipment IQ/OQ, Software IQ/OQ, Process OQ, Process PQ etc.).
• Understand and follow SOP's and DOP's. Follow and comply with GMP, GLP and FDA guidance.
• Practices, with Process Validation/Test Method Validation (including process development capabilities), Equipment Qualification/Computer Systems Validation (CSV) and Cleaning Validation.
• Good in validation documentation as required (plans, protocols, reports, procedures etc.).
• Good in Regulatory Submission documentation experience and document management (Documentum) experience.
• Good knowledgeable in ISPE Commissioning and Qualification Guidelines. Have developed and implemented qualification master plans, impact assessments, test plans, SOP's, and commissioning and qualification protocols.
• Well versed with Software Development Life Cycle (SDLC) methodologies with emphasis on quality assurance and testing practices.
• Good knowledge of HP Quality center.
• Excellent analytical, problem solving, communication and interpersonal skills with good work ethics and ability to interact with individuals at all levels of the organization.
• Have very good working knowledge on UNIX and SQL.

TECHNICAL SKILLS

Tools: Quality center,Windchill V 9.1, MS Office Suite Word, Excel, PowerPoint, MS Visio, MS Project.

Operating System: Windows 2000/2003/XP/Vista/7

Methodologies: Waterfall, V-Model, SDLC

FDA Regulations: 21CFR Part 11 (Electronic Records, Signatures), 210-211 (cGMP’s), 803 (Medical Device Reporting), 820 (Quality System Regulation).

Validation Deliverables: Validation Plan, Test Plan, Compliance Risk Profile, RTM, URS, FRS, OQ, PQ Protocols, Sop’s/Work instructions, System problem reports and System Certification Summary/Compliance Report.

PROFESSIONAL EXPERIENCE

Confidential, PA

Validation Engineer

Responsibilities:

• Involved in all phases of Computer System Validation (CSV) Life Cycle to comply with FDA regulations particularly 21 CFR Part 11 and Annex 11.
• Responsible for authoring and reviewing Standard Operating Procedures (SOPs), URS/FRS, DS, Risk Assessment, IQ/OQ/PQ Protocols, Deviation Management, Traceability Matrix and Validation Summary Report.
• Documented Requirements Traceability Matrix (RTM) to track the requirements.
• Involved in performing Risk Assessment and proposed improvement suggestions on Validation processes for SAP V 4.7 for Material Management (MM), Production Planning (PP), Quality Management (QM), Warehouse Management System (WMS) & Sales & Distribution (SD) Modules. Risk assessments also included SAP & Windchill V 9.1 Interface.
• Ensured that all the high risk requirements are covered in OQ/PQ testing.
• Wrote Performance Qualification scripts for end-to-end Business use of SAP R/3 V 4.7 (Scripts for ERP - SAP system and non-ERP - Systems Windchill).
• Responsible for the Quality review of all Validation and Engineering Qualification protocols and reports for adherence to cGMPs, good documentation practices, and general quality oversight.
• Created, modified, maintained, archived and retrieved electronic records to be submitted to FDA for inspection.
• Validated LIMS to ensure 21CFRPart 11, electronic records, electronic signatures and cGxP compliance
• Worked with Engineering and Validation areas to coordinate execution activities and to resolve compliance issues.
• Worked closely with engineering disciplines during design phase conducting cGMP design reviews and development of the Validation Master Plan.
• Additional responsibilities included development of protocols (IQ/OQ/PQ).
• Performed Validation Testing on the application in accordance with FDA guide lines.
• Involved in preparing Validation Strategy Document (VSD).
• Reviewed User and Functional Requirement Specification (UFRS), Requirements Traceability Matrix (RTM) and IQ/OQ/PQ Scripts.
• Responsibilities included IQ, OQ, IC (Installation Commissioning), and OC (Operational Commissioning), writing and execution, review of turnover packages, and assistance in the resolution of deviation notices.
• Generation, execution and close-out of deviation reports and protocol Amendments.
• Assist in the review of PQ deviations. Generated and maintain the project schedule to comply with client critical dates and manufacturing areas requirements.
• Verify receipt of approved documentation according to the Client requirements.
• Good experince on Trackwise validation.
• Coordination of Project Meetings and presentation of project progress.
• Used MS Project to track project progress against project expectations, due dates.
• Proper maintenance of Electronic Records and Electronic Signatures.
• Extensively used SQL queries for data verification using TOAD.

Confidential, Columbus, IN

Validation Engineer

Responsibilities:

• Responsible for creating and executing protocols, requirements traceability and reports in accordance with company SOPs, project plan and product specifications.
• Determine validation requirements for processes.This includes validations related to new product launches, new equipment, re-validation associated with change control, and validation of existing equipment to meet regulatory requirements.
• Involved in authoring, reviewing and approving various Validation Deliverables (e.g. Validation Plan, SOPs, URS/FRS, IQ/OQ/PQ Protocols, Test Scripts and Summary Reports etc.).
• Monitor and maintain listings of validation records and ensure that records are adequately defined, complete, and archived.
• Manages the preparation of study documentation packages, which include data review and summary of each assessment for presentation to management and regulatory agencies, ensuring compliance with cGMPs.
• Developed listing of required quality records and ensure that records are adequately defined, complete, and archived.
• Development of Master Validation Plans and ensuring that the plan requirements are fulfilled including timelines.
• Updating and refining the validation template system for streamlining validation implementation.
• Define validation completion and change control performance measures and implement trending for long range goals and plans for continuous improvement.
• Assist in identifying risks and conducts risk mitigation testing.
• Maintaining Defect logging and closure according to SOP.
• Performed Gap Analysis and compliance audits on existing operations/documentation and supporting the client’s development of a remediation plan to address the deficiencies.
• Assisting and conducting compliance assessments, equipment qualification and validation. Assisting in the development of SOPs, preventive maintenance, systems integration, and change control.
• Work with clients to evaluate systems and operations for compliance against both internal policies and FDA regulatory compliance.
• Coordinated meetings with upper management to discuss project status and progress.

Confidential, Temecula, CA

Validation Engineer

Responsibilities:

• Project involved integration of analytical instruments (HPLC, Spectrophotometers and pH/EC meters) and validate the complete system for compliance with FDA regulations.
• Involved in validating computer system interface with laboratory equipments such as spectrophotometer, HPLC, GC, Autoclave, Temperature monitoring devices, freezers, refrigerators etc..
• Implemented and maintained a successful cleaning validation program.
• Assess equipment and products, impact on routine processes.
• Determined appropriate cleaning methods and agents and developed acceptance criteria for the residue (including cleaning agents) and degree of evaluation required to validate the procedure.
• Acquired and documented the business requirements.
• Hands on experience in formulating Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ) for validating.
• Executed IQs, OQs and PQs to check the functionality of the system.
• Generated Validation Summary Report to summarize and document all validation activities.
• Reviewed Standard Operating Procedures (SOPs) for various functionalities.
• Performed Cleaning Validation for healthcare device manufacturing.
• Involved in the process validation of Autoclave and Incubator.
• Involved in Process Failure Mode Effects Analysis(PFMEA) completion.
• Analyzed test scripts to check whether all functionalities have been covered within the compliance of 21 CFR Part 820.
• Developed test scripts and test cases for automated and regression testing using Quick Test Professional (QTP).
• Responsible for ensuring the compliance of GMP/GLP and FDA regulations.

Confidential, San Diego, CA

Validation Engineer

Responsibilities:

• Project involved the development of clinical trial research form of coronary heart disease and development of the clinical trials through the web-based application.
• A member of assessment team to study the 21 CFR Part 11 requirements.
• Involved in preparing documentation for all aspects of the computer system validation lifecycle, in accordance with FDA regulations, particularly 21 CFR Part 11 including IQ, OQ and PQ specifications.
• Maintained and documented SOPs.
• Coordinated with the System Analyst, Project Manager and Business Analyst to set up the pre validation and validation and validation environment to execute the scripts.
• Responsible for calibrating, troubleshooting and maintaining the laboratory equipments including GC, HPLC, spectrometers, autoclaves and pH meters etc.
• Developed Requirement Traceability Matrix (RTM) to track requirements and to align the work process.
• Involved in developing and implementing the test strategy and performed various analyses.
• Regular interaction with Designers, Developers and System Analysts.
• Analyzed the requirements and critical areas of the application to setup and execute baseline tests.
• Performed GAP Analysis, Remediation Plan and maintenance of hybrid systems, closed and open record systems.
• Drafted SOPs and trained users on these systems and the implications and impact of 21 CFR Part 11 compliant data systems on the day-to-day functions.
• Involved in preparing compliance report about existing status of cGMP, cGCP and cGLP.

Confidential

Process Engineer

Responsibilities:

• Verified and validated System security, Authority Checks, Operational Checks for Waters Empower, SoftMax and Agilent ChemStation compliant with ISO regulations.
• Qualified Chromatography (HPLC, GC, LC/MS) sequence data and reports on samples, for accuracy, clarity and traceability.
• Performed different sterilization techniques such as moist heat sterilization and etlylene oxide cleaning techniques.
• Followed the Standard Operating Procedure (SOP’s) of the company in documenting Test Plan, Test Cases and Test Procedure using Business Requirements Document (BRD) and Functional Requirements Document (FRD) of the system.
• Involved in writing and execution of qualification protocols like IQ, OQ and PQ.
• Maintained Traceability Matrices for mapping the requirements to the test cases.
• Conducted User Acceptance Testing (UAT) before the initial release when the project reached the final phase prior to deployment.
• Actively participated in preparing the Test Summary Report (TSR).
• Developed QA documentation for the ISO audits.