PROFESSIONAL OVERVIEW:

A dedicated and results - driven health care professional with over 7 years of experience in the Pharmaceutical, Biotech, Drug, and Device Manufacturing industries. Detail oriented with strong business, planning, validation, implementation skills in the design, development, testing, validation, deployment, and support in the Software development lifecycle of a project-with strong focus in the manufacturing and production of planning applications, Change Control Management testing, and GMP procedures. Exceptional communication and inter-personal skills.

PROFESSIONAL SUMMARY:

• Extremely knowledgeable with the Software Development Life Cycle, ISO, EU-MDR, Validation Plans, IQ/OQ/PQ/RTM, validation reports, SOP’s, GAMP 5, 21 CFR Part 11, ITIL, risk analysis, testing and implementation of a project
• Reviewed and Validated Computer Systems in compliance to 21 CFR Part 11 and QSR 820
• Experience in generating and reviewing Computer Systems Validation (CSV) Deliverables according to 21 CFR Part 11 and FDA regulations
• Working knowledge of GLP, GCP, GMP, GAMP guidelines in areas of computer or related systems
• Experience in the preparation and reviewing of protocols (IQ, OQ, PQ) documentation, Labeling, Validation Reports, Validation Summary Reports, SOP’s, Risk Assessment, Periodic Review Report, and resolution of protocol deviations or non-conformances
• Experience in developing and reviewing User Requirement Documents, Functional Requirement Specification, and the Requirement Traceability Matrix
• Record of accomplishment in providing definitive compliance expertise for SOP’s, hardware, software, performance requirements and documentation
• Well versed in phases of clinical trials, pharmacovigilance and GCP as of 21 CFR 50 and 56
• Dedicated team player, flexible and able to work independently
• Strong presentation, verbal and written communication skills, and the ability to interpret complex instructions
• Leadership skills, well organized, assertive, and confident

TECHNICAL SKILLS:

SQL 2008, Oracle 10.x, Windows 7, XP and 2000, MS Office (Excel, PowerPoint, Word), MS Project, MS Share Point, Visio, SAP Front End, eDOCS

Test Protocol Design, SDLC, Requirement Analysis, Test Plan, Validation Plan, SOP, GAMP, User Acceptance Testing using HPQC 10.0

21 CFR 11, GLP Requirements, CAPA, 21 QSR 820 (Risk Management), 21 CFR 210/211 (GMP), 21 CFR 56 (GCP), 21 CFR 58 (GLP), Annex 11, 21 CFR Part 50 (Informed conent), 21 CFR Part 312 (New Drug), GAMP, FDA rules and regulations

Protein and Enzyme Assays, Tissue Culture

EXPERIENCE:

Confidential, Berkeley, CA

Computer Systems Validation Specialist

Responsibilities:

• Authored Lifecycle Documents such as SDS, FRS, URS, DQ, CMP, TM, Validation reports, Risk Assessments etc
• Performed gap analysis, reviewed and approved action plans to ensure compliance during and after the system validation
• Reviewed and approve System Design Life Cycle documentation
• Authored and executed Validation protocols such as IQ, OQ, PQ
• Reviewed and approved of various SOPs for systems
• Prepared Validation reports for executed protocols
• Authored Periodic Reviews on various systems such as FTIR, HPLC, Hamilton Chromogenic, Densitometers, Atomic Absorption Spectrometers etc
• Worked with SharePoint, LIMS and implementing Empower 3 (verifying the connections to the PC and software were working)
• Commissioned various instruments and software such as AAs and software, SoftMax Pro 7.
• Decommissioned various instruments and software such as Empower 2 software, HPLCs, FTIRs etc
• Authored repair protocols and reviewed vendor documentation in ensuring it meets Bayers standards
• Trained to assist in lab tasks such as packaging or samples or material combinations or running system suitability tests.
• Apollo Project Data Integrity Gap: Authored the SDS for SoftMax Pro 4.7.1 and accompanying protocols to test the verification of the settings for the software.
• Assisted various labs such as Potency, Chemistry in sample testing for their tasks
• Experienced in Change Coordination procedures such as CCRs, CA, CAPAs and deviations and in understanding exception reports.
• Initiate / monitor and track to closure of changes and CAPAs and closed out deviations
• Knowledgeable in GAMP5, V model, GXP Processes' etc.
• Administrator for certain systems (password resets, or logging into the system) and assisted in resolving technical and project-related issues.
• Experience with labeling of instruments that needs to be validated.
• Assisted and provided training related to computerized systems validation, quality and compliance to users and appropriate personnel in audits or inspections
• Knowledge of testing methodologies such as defect management, test plan and test cases preparation
• Knowledgeable on numerous equipment such as Densitometers, Atomic Absorption, HPLC, FTIR, Hamilton Chromogenic, UV-Vis etc. Softwares such as SoftMax Pro, Venus, Omnic, Empower, Chromquest, ImageLab etc
• Expertise in interpretation of the applicable regulations that impact computer systems (e.g., 21 CFR Parts 11, 50, 58, 312) used in GxP environment and related FDA guidelines, regulations, as well as ICH GCP guidelines.

Confidential, New Brunswick, NJ

Validation Engineer

Responsibilities:

• Validation of HPLC (High Performance Liquid Chromatography) laboratory systems
• Validation Plan for similar 6 HPLC systems of laboratory systems which were integrated with Empower User and functional requirements with Part 11 Functionalities Responsible for testing strategy, Test Plan & Protocol, IQ, OQ, PQ, RTM, GAMP 5 model, SOP, and Validation Summary Plan the validation effort based on risk assessment (GxP) and regulatory assessment Provided inputs for writing Computer Work Instructions
• Validation of Total Organic Carbon Analyzer (TOC) laboratory systems
• Responsible for User and functional requirements with Part 11 Functionalities Responsible for Test Plan & Protocol, IQ, OQ, PQ, RTM, and Validation Summary
• Validation of FTIR (Fourier Transform Infrared Spectroscopy), UV/Vis laboratory systems
• Authored the deliverables - Validation Plan (VP), Requirement Specifications, Test Plan and Protocol, Requirement Traceability Matrix (RTM) and Validation Summary Report (VSR)
• Periodic Review of various laboratory and enterprise systems
• Reviewed Performance Monitoring Plans, Quarterly Performance Monitoring Summary Report Reviewed Validation deliverables, Change Control Logs, Production Log, Event Log, Platform Log, Database Change Logs Performed Risk Assessment Review SOPs / Computer Work Instructions (CWI) / Laboratory Equipment Procedures (LEP) against business use, local policies / procedures, and regulations Review user training log, user log, user manual, technical support manual, calibration records and preventive maintenance records Advised on bringing systems to complete compliance Summarize the review and recommendations in Periodic Review Report Performed Periodic Review on Ab Initio (Data Warehousing tool), SAS Tool, Excel Spreadsheets, Spectrophotometers, Particle Size Analyzers

Confidential, East Bridgewater, MA

Pharmacy Technician

Responsibilities:

• Processed orders and provided exceptional medical care to patients
• Assisted pharmacist in packaging and delivering products to the patients while excelling in pharmaceutical procedures
• Explained the medicinal and treatment processes while assisting the pharmacist
• Managed inventory for the pharmacy
• Ability to interpret written prescriptions and perform needed calculations
• Input customer and prescription data into the computer via Rx Connect
• Answered patient questions and resolved them quickly and efficiently
• Assist patients with drug therapy and pharmacy care issues
• Major communicator between patient, insurance companies, pharmacist, nurses, lab technicians, and other healthcare related parties
• Maintained good relationships with healthcare practices
• Maintained a clean, sanitary work environment

Confidential, Rochester, NY

Validation Analyst

Responsibilities:

• Developed User and Functional requirements for the application and documented the required changes as per Computer System Validation Master Plan.
• Reviewed the system requirements document.
• Created the Validation Test Plan Protocol and Test Criteria.
• Wrote the Validation Risk Assessment for the system including mitigation strategies.
• Developed the process flow in consultation with the business and process teams.
• Involved in deviation investigations, SOP preparation and quality system development, and equipment qualification.
• Completed a flowchart for Sample Manager and Labware LIMS to demonstrate appropriate workflow functionality.
• Co-coordinated with Systems owner and Business analyst to setup Pre-Validation and Validation environment to execute the scripts.
• Involved in preparing compliance report including 21 CFR Part 11 functionalities with the existing status of the cGMP sensitive computerized systems.
• Used HPQC Quality Center for theesting, and for tracking and reporting test defects.

Confidential, Canton, MA

Validation Analyst

Responsibilities:

• Involved in Validation of Lab Instruments (FTIR (Fourier transform infrared spectroscopy) & HPLC Shimadzu Series)
• Involved with Risk Analysis and prepared and reviewed remediation Procedures, Test cases & Validation Summary Reports
• Analyzed as is functional specifications and requirements to categorize the units.
• Developed SOPs, System Admin., and Instrument Operating Procedures.
• Developed Protocols IQ, OQ and PQ
• Involved in the design and implementation of data collection, analysis and validation using MS - Access and MS Excel.
• Developed User Acceptance Protocol to describe the specific objectives, procedures, data setstest scenarios, expected results, and acceptance criteria for the PQ/ UAT process
• Used authority checks to ensure that authorized individuals can enter, sign or change data
• Involved in writing protocols for stress testing and performance testing
• Involved in the execution of Test Protocols (IQ, OQ and PQ)
• Participated in all Project Meeting and involved resolution of various issues