SUMMARY

• Over 5+ years of experience in performing validation of system, Technical Writing, Quality Assurance and Quality control. Seeking an opportunity to work as a system validation engineer where my validation skills can be used in implementation and supporting projects in a renowned organization.
• Good hands on experience and understanding in Software Development Life Cycle (SDLC), familiar with Waterfall, V - shape models in relation to development and testing.
• Validate the data migration process for Customer Master, Material Master and Item Master to convert the data from legacy systems into SAP.
• Validation of SAP ECC 6.0 system including Manufacturing, Procure to Pay, Warehouse Management and Order Management, LIMS and multiple in-house applications.
• Experience in Validation with strong background in CSV, Process Validation,Test Method Validation.
• Equipment Validation and Cleaning Validation.
• Strong understanding of 21 CFR Part 11 drug cGxP (GMP, GLP and GCP)requirements including electronic records, electronic signatures, system validation strategies and documentation.
• Expertise in pharmaceutical industries using modern analytical methods and techniques in the field of Quality Assurance, Quality Compliance and Manufacturing.
• Expertise in Development, review and approval of IT SOPs,CSV master plans.
• Expertise in preparing and reviewing User Requirement Specifications (URS), Functional Requirement Specifications (FRS) and Design Specifications (DS) in compliance with FDA rules and regulations.
• Comprehensive knowledge and extensive experience in preparing and reviewing Test Plans, Validation protocols (Installation Qualification - IQ, Operational Qualification -OQ and Performance Qualification - PQ).
• Developed Test Summary Report and Requirement Traceability Matrix(RTM) Virtualization Summary Report(VSR)
• Proficient in developing Test Scripts, Test Cases, Test Plans, Test Procedures, Test requirements and testing standards.
• Good experience of performing Gap analysis and preparing Remediation Plan, Risk Assessment, Change Request and Deviation report.
• Experience in handling Analytical instruments like HPLC(Agilent&Waters),Dissolution,Ph meter and use of this knowledge in LIMS application.
• Experience with Information Request Management System (IRMS), Laboratory Information Management System (LIMS), Adverse Events Reporting Systems (AERS), Change Control Management System, SAP R/3 and Enterprise Document Management System (EDMS).
• Good understanding of Sarbanes Oxley Regulation (SOX), Sunshine act, Information Technology Infrastructure Library (IT-IL) guidelines.
• Knowledge in interpretation of guidelines, audit procedures, Documentation and departmental policies and procedures.

TECHNICAL SKILLS

Computer System validation: 21 CFR Part 11 … 820), (IQ, OQ, PQ) Protocols, GAMP, cGXP (GDP, GLPGMP), IRMS,LIMS,TMS, AERS, RTM, SOPs, Summary Reports, Audit Trails, Gap Analysis, Remediation.

Business Tools: MS Office (Word, Excel, Power Point, Access, Visio),Track Wise 7.0, LIMS,EDMS, TMS, AERS, Process Compliance 2.5 and SAP R/3 HP Quality Centre, JIRA, Share Point, TRAC

Testing Tools: Quick Test Professional (QTP), Winrunner,Test Director, SAP eCATT, MES

Operating Systems: Windows 95/98/NT, 2000,XP, Unix

Laboratory Equipment: HPLC (Agilent; Waters; Shimadzu), Dissolution Testing Apparatus, UV& IR(Spectrophotometer), Karl Fischer titrator, Incubators, Autoclaves, Sieve shaker, Tap & Bulk density Friabulator, Ultra Sonicators, Filtration Degasser, Ovens, and pH meters, Weighing balances.

PROFESSIONAL EXPERIENCE

Confidential, Valenica,CA

Validation Engineer

Responsibilities:

• Involved in validation of SAP ECC 6.0 implementation and Web Applications in accordance with Company policies and procedures.
• Involved in meetings with users to review and approve Business Process Procedure (BPP), User and Functional Requirement Specifications (URS & FRS).
• Reviewed and approved Installation Qualification IQ), Operational Qualification (OQ) and Performance Qualification (PQ).
• Developed Validation Plan, Traceability Matrix, Master Test Plan, Validation Summary Report documents.
• Created and Reviewed Test plans, test cases, for IQ, OQ, and PQ protocols based on requirements of the application.
• Wrote Standard Operating Procedures (SOP s) for all aspects of the validation life cycle, in accordance with FDA regulations, particularly 21 CFR Part 11 and GxP regulations.
• Developed Traceability Matrix to keep track of relationship between Requirements and Test Scripts.
• Involved in Qualifying the Web applications, Client/Server applications according with 21 CFR part 11 requirements like Security, Audit Trail etc.
• Developed Validation Deliverables that are required by SDLC policy and FDA regulations.
• Conducted assessments of regulated systems to assure validation procedures have been followed in compliance with company, divisional and departmental policies and predicated rules.
• Involved in generation and implementation of QA and QC procedures and policies.
• Involved in Gap Analysis, Risk Analysis and prepared Remediation plans.
• Conducted Periodic Evaluation to demonstrate that system remains in a validated state in its life cycle.
• Developed Validation Summary Report (VSR) to summarize all validation activities.

Confidential, Carlsbad, CA

Computer System Validation Intern

Responsibilities:

• Validated other computerized laboratory equipment, such as Distributed Control System (DCS) Building Management System (BMS), Facility Monitoring System (FMS), Filtration System, Integrity Testing Machine, Kaye validator, Data Logger.
• Completed 21 CFR Part 11 compliance assessments of laboratory and manufacturing systems, including remediation and validation of deficient systems.
• Trackwise Coordinator maintain Change Control Request, Deviation, CAPA.
• Involved in the Global Implementation and Validation of Global IT applications, CAPA, CCM Workflows and IRMS.
• Directed cleaning validation studies, including development of sampling techniques, validation of trace level analytical methodology, preparation of SOPs, assignment of limits, and presentation of results.
• Vendor Coordination (Required documentation VSF, ERES, DQ, FRS with vendor)
• Completed SDLC documentation IQ, OQ, and PQ of manufacturing equipment, such as BMS, DCS, FMS, Kaye Validator, Filtration System, and Data Loggers.
• Prepared SOPs describing validation policies, change control procedures, and equipment operation.
• Experience in using HPQC for creating test plans, test scripts and cases and also for creating and tracking defects.

Confidential

Validation consultant

Responsibilities:

• Analyzed Computer System Validation documents including User Requirements (URS) and Functional Specifications (FS) for DOORS, IAS, MiniTab.
• Wrote the system test cases according to specifications and requirements and in compliance with 21 CFR Part11.
• Maintained Change Control documentation in accordance with SOPs, Conformance standards and company methodology.
• Reviewed existing validated documentation and evaluated executed changes controls, reported problems, and vendor upgrades/patches in order to determine if any actions are requires such as upgrading, replacement or re-validation.
• Trained users on the system implication and provided an independent oversight about an impact of 21CFR Part 11 regulations.
• Daily conducted scrum meetings with analysts.
• Participated in regular project meetings and requirement/process review meetings.
• Closely worked with Subject Matter Experts (SME's) and Computer System's Owners (CSO) for gathering the requirements.
• Validated PLC and Human Machine Interface for process equipment
• Strong knowledge on GxP and hands on experience in 21 CFR Part 820 and 21 CFR Part 812 (Product Design, Product and Process Development).