Validation Specialist

Mayuri Reddy

Senior Validation Analyst

Contact: 732-***-****

Email: ************@*****.***

Available for C2C only

Summary:

Over 7 (Seven) years of experience in Pharmaceutical, Biotech and Drug Manufacturing Industries focusing on Computer System Validation, Process Validation, Instrument Qualifications and Software Quality Assurance.

Hands on experience in developing and documenting Validation Plan, Validation Summary Report (VSR), Requirement Traceability Matrix (RTM) and Standard Operating Procedures (SOPs)

Experience in developing Validation protocols, Executing tests and preparing Summary Reports for IQ, OQ and PQ for validations in various pharmaceutical companies

In depth knowledge of FDA regulations like 21 CFR Part 11, 21 CFR Part 820, 210,211 and other SOX, GxP (GMP, GCP, GLP, GDP) regulations and GAMP5 guidelines.

Experience in validating a wide variety of applications like LIMS and Track wise.

Experience in writing Risk Analysis, Gap Analysis, and CAPA documents

Developed comprehensive Test Summary Report and Test Cases

Hands-on experience in using tools like HP-QC/ALM.

Have good knowledge in SQL queries.

In depth knowledge of Software Testing Methods.

Good knowledge on Change Management System.

Have been exposed to different phases of SDLC methodology

Extensive Experience in Enterprise Document Management System (EDMS) with automated systems such as Documentum and Mastercontrol.

Extensive Experience in working with MS Visio, PowerPoint, Word, Access and Excel.

Excellent Coordination skills, Communication skills and strong Technical Writing skills and a good team player.

Proficient in learning new technologies and quick at adapting to new environment.

Able to accomplish tasks without supervision.

Education:

Masters in Information System Management

Bachelors in Pharmacy

Technical Skills:

Validation

FDA regulations, 21 CFR part 11, GXP (GDP, cGMP, GCP, GLP) SOPs, GAMP, GAP analysis, audit trials, summary reports.

Methodologies

Agile, Waterfall and V-model

Applications

LIMS, HP-QC, Track Wise, Documentum, Mastercontrol

OS and Applications

Windows (XP/2007/2010), Unix, MS Word, MS excel, MS power point, MS Visio, MS Access

Technical Writing

Validation Master Plan, Functional Specification, User Requirement Specification, Test Summaries, Requirement Traceability Matrix(RTM), Release to Production memo.

Analytical Instruments

HPLC, UV-VIS Spectroscopy, IR Spectroscopy, Autoclave

Professional Experience:

Company: West Pharmaceutical Services Exton PA Sept 2016 to Current

SAP Validation Specialist

Involved in Validation of SAP system on Project FUSION. Project FUSION is a multi-year SAP convergence of two SAP ERP systems (the North American and Europe / Asia Pacific regions).

•Reviewed the following validation deliverables to ensure that SAP system satisfies regulatory requirements of the FDA and other authorities like SOX, 21 CRF part 11.

•Managed and Maintained Document Naming Convention of all document deliverables

•Performed Risk Based Assessments.

•Approved Pre and Post execution OQ and UAT documents

•Reviewed Pre and Post execution of IQ, OQ and UAT documents

•Assisted in Incident Resolution during the OQ and UAT execution

•Reviewed applicable policies and procedures that are being created/ updated as a result of FUSION

•Created the following validation deliverables - Validation Master Plan, Release to Production Memo, Business Verification Memos, Validation Summary Report, Requirement Traceability Matrix

•Uploaded the Validation Deliverables into West Document Management System for approval (MasterControl)

•Make Recommendations for improvements in process and documentation practices.

•Guide IT team on Good Documentation Procedures related to cGMP and other regulatory requirements.

•Provided Status Updates on a weekly basis

•Create, manage, schedule and worked closely with project manager on all documents related to project lifecycle.

•Worked with offshore team in managing the CSV deliverables

•Involved in Internal Audit

•Involved in Change Control through Service Manager in reviewing and approving the changes.

Environment: SharePoint, Mastercontrol, MS office, V-model, ServiceManager.

Company: Enteris BioPharma, Boonton, NJ Dec 2015 to Aug 2016

Senior Validation Analyst

Involved in Validation of Lab Instruments like UV Spectrophotometer and HPLC.

Responsibilities:

•Supervised validation schedule and maintained Validation deliverables, periodic review report, Test cases Validation Reports.

•Developed SOPs, Protocols and Plans.

•Performed Risk Assessment to reduce the testing efforts and reduce validation efforts.

•Provided technical training to validation team in preparing validation protocols, executing them, and interpreting test data.

•Obtain and respond to QA review and apply QA expertise to review guidelines, process, policies and assist in the development of QA Plan and procedures and their implementation with multiple validation audit inspection and GMP/GLP/GCP compliance process.

•Performed pre and post review and approval of test scripts.

•Involved in in the resolution of validation deviations and test defects.

•Assisted Cleaning Validation activities of swab sampling using TOC analyzer.

•Liaise with other team members/departments to develop quantitative scoring of risks in functional requirements following the risk assessment procedures to ensure Quality standards are met; and to communicate and resolve regulatory issues that arise, draft/final report in timely manner to the Management/Client.

•Developed and executed User Acceptance Protocol Test Plan, test strategy, detailed test Subjects to describe the specific objectives, procedures, data sets, test scenarios, expected results, and acceptance criteria.

•Development, approval and execution of validation protocols. (IQ/OQ/PQ)

•Performed Gap Analysis and compliance audits.

•Worked collectively with team to keep them informed of project status.

•Coordinated with SMEs (Business Owners) on laying out the approach for testing strategies.

Environment: Agile, UV-VIS Spectrophotometer, HPLC, Empower, Trackwise.

Company: Ortho Clinical Diagnostics Raritan NJ Feb 2015 to Nov 2015

Validation Specialist

To provide a user friendly and technically enhanced LIMS system, company is implementing Thermo Lab Systems Sample Manager. Sample Manager is designed to maintain an auditable record of work carried out in a laboratory environment.

Responsibilities:

Involved in developing the Compliance plan to identify the overall strategy and list of deliverables for validating the system.

Assisted the team in generating the requirements specification and involved in documenting it in compliance with regulations.

Responsible for developing the Data Migration Plan.

Used SQL queries to create the Test Analysis Report for Data Migration End-to-End System Test.

Performed GAP analysis, Root Cause Analysis of system and identified GAPs to meet the current standards.

Involved in review of Remediation plan to remediate the identified GAPs for respective system.

Executed and reviewed PQ (Performance Qualification), OQ (Operation Qualification) protocols to check successful operation of the application.

Documented and reviewed IQ (Installation Qualification) protocol.

Created Traceability Matrix to map the requirements to the protocols.

Followed GDP while Documenting test scripts and developed a summary report.

Worked on the FDA regulations 21 CFR part 11 electronic records, electronic signatures and final rule electronic submissions.

Reviewed User manuals and Training manuals for alignment with the SOPs

Environment: Agile, Share Point, MS Visio, Windows 7, SnagIt, LIMS, HPQC, Microsoft Office Suite (Word, Excel, Power point, Access), MS SQL.

Company: Integra Life Sciences, Plainsboro, NJ Jan 2014 to Jan 2015

Validation Analyst/ Tester

Involved in assisting in Validation activates and help implement Change Control systems for Seibel CRM system. Involved in reviewing existing validated documentation (Siebel applications) and documenting change control documentation using Trackwise.

Responsibilities:

Responsible for analyzing and reviewing validation deliverables like Validation Plan, User Requirement specification, Functional requirement Specification, System Design Specification document.

Involved in periodic review and closing the CAPA.

Worked on change control documentation such as Change Request Form (CRF’s), Change Control Implementation Plan, Change Control Summary Report.

Ensuring Change Controls are routed in a timely manner.

Responsible for review and approval of the test scripts in quality center.

Authored and reviewed Requirement Traceability Matrix (RTM)

Responsible for working with internal and external auditors in facilitating the system audits.

Tracked defects while testing and reported using HP Quality Center and manual testing.

Reviewed and modified existing Standard Operating Systems (SOPs) for Document management system and Testing SOPs.

Worked with the business unit to ensure that the validated state of the system is being maintained and meets the corporate and regulatory guidelines.

Environment: Waterfall, Share Point, MS Visio, Windows 7, SQL, Track wise, HPQC.

Company: Watson Pharmaceuticals, Corona, CA Oct 2012 to Dec 2013

Computer System Validation Analyst

To ensure overall compliance with cGMP in the pharmaceutical manufacturing environment. To maintain focus on Quality Control and Quality Assurance functions of the SCADA, PLC systems in the manufacturing industry.

Responsibilities:

Involved in interaction with Business Owners, System Owners, Business Analyst and Technical Writers

Documented the validation plan.

Participated actively in requirements reviews.

Analyzed Business, User and Functional requirements to develop Test Plans, Test Cases and Test Scripts.

Prepared test summary reports for all the executed test scripts and per GDP.

Wrote deviations for all the errors encountered during execution of the test scripts.

Developed Requirement Traceability Matrix (RTM) to track User and Functional requirements.

Assisted the project manager with the timelines for validation deliverables.

Created Validation Summary Report (VSR) to summarize overall validation effort and capturing any errors and its resolutions.

Environment: Water fall, MS Word, Oracle SQL Developer, MS Visio, Windows 7.

Company: Sun Pharmaceuticals, Hyderabad, India Aug 2009 to Sep 2012

QA Analyst/Tester

Applications Security Weaver for password re-set, SAP front end for routing for approval and maintaining document.

Responsibilities:

Involved in Documenting User Requirement Specifications and Functional Requirement Specifications.

Assisted in the development of test scripts and executed the test scripts for OQ and PQ testing and provided the evidence.

Performed positive and negative testing.

Identified, tracked and reported on the bugs during the entire testing process.

Performed Regression testing on the application after retesting the bugs.

Analyzed test results and documented them.

Documented the Test Summary Report.

Ensured compliance with business requirements, company policies and procedures and regulations.

Environment: Water fall, MS Word, MS Visio, Windows XP.

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