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Management Quality Assurance

Location:
Valencia, California, 91354, United States
Salary:
80K
Posted:
October 16, 2016

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Nagasree Immidisetti Phone: 337-***-****

Validation Consultant Email: acw2qf@r.postjobfree.com

Authorized to work in the US for any employer

Career Objective

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.

Professional Summary

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, GLP,

GMP), 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

Advanced Bionics, Valenica,CA. Dec 2014 – Present

Validation Engineer

Advanced Bionics is a global leader in developing the most advanced cochlear implant systems in the world. It is specialized in manufacturing implants, high technology neurostimulation devices.

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.

Life Technologies, Carlsbad, CA Feb 2013 – Nov 2014

Computer System Validation Intern

Life Technologies is a global leader in manufacturing Food and Drug Administration regulated products, assays and advanced cells systems used in a variety of applications for the life science research and medical community

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.

Cipla Pharma Ltd, Hyderabad, INDIA March 2009 – Oct 2010

Validation consultant

Cipla is a global pharmaceutical company which uses technology and innovation to meet every day needs of all the patients.

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).

Education :

Bachelor of Technology, JNTU, India

References:

Available upon request



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