Quality Management

SATISH

Summary:

Over * + years experience in Pharmaceutical, Manufacturing, Medical devices with the focus on Equipment and Computer Systems Validation (CSV) as a Validation Analyst/Quality and compliance analyst/Technical Writing Testing and with strict adherence to GAMP & cGMP regulations (cGMP, GLP, and GCP).

Superior knowledge of GAMP, GxP's (GCP, GLP and GMP), 21-CFR Part 11 regulation of Electronic Records, Electronic Signatures and Audit Trails.

Strong knowledge on all software development life cycles (SDLCs) like Waterfall, Agile and V-models.

Knowledgeable of cGMP, CFR's, ISO, ICH guidelines applicable to Drug Product, Drug Substance and Combination Product manufacturing. Experience performing GAP Analysis, Complaint Investigations, Supplier Qualification.

Internal and External Audit management, Deviation Management, Data Trending, Change Management and Training/Certification. Experience includes roles in Quality Control, Production, Research & Development and Quality Assurance with domestic and international pharmaceutical and medical device manufacturers.

Skilled at driving to root cause through comprehensive and thorough investigations utilizing process and risk based management tools resulting in effective corrective and preventative actions.

Detailed understanding of the Quality Assurance process with respect to system compliance.

Experienced in developing SOPs and User Manuals in preparation to support the production system. Expertise in reviewing, development and modifying documents related to Computer Systems Validation Lifecycle (CSV) such as Validation Master Plan (VMP), User requirement specification (URS) Functional requirement specification (FRS), Installation Qualifications (IQ), Operational Qualifications (OQ), Performance Qualifications (PQ), Configuration Management, Validation Summary Report (VSR), Test Summary Report, Periodic review report, designing Requirement Traceability Matrix (RTM), Deviation Reporting, Design Specification (DS), Source code Review (SCR), Risk Assessment, Business continuity plan (BCP), Disaster recovery plan(DRP), Change Control, and Incident

Knowledgeable in domestic and international regulatory requirements for Medical Devices, combination Device/Pharma, MDD, 21CFR part 11, 801, 812, 814, 210, 211)

Proficient in reviewing and documenting validation protocols like Performance Qualification (PQ), Operational Qualification (OQ) and Installation Qualification (IQ) protocols.

Performed Test Method Validation (TMV's) for Medical devices, Receiving Inspection and Return products analysis Labs.

Partner with QA/RA on validation activities in preparation of pending regulatory submissions (PMA), and follow-on audits.

Proficient in Technical Writing with strong experience in developing Enterprise Lifecycle Documentation required for application development projects like Project Plan, URS, FRS, FDS, RTM, Test Plan, and conformance with FDA rules and regulations.

Proficient in performing CAPA Analysis and writing Remediation Plans.

Experience working with and validation of Laboratory Information Management System (LIMS), Track Wise, Change Control Management System (CCMS), Adverse Event Reporting System (AERS) Spreadsheet and Report Validation.

Implemented Trackwise as a complete end to end solution to address the implementation of Product Complaints Handling, Investigation, (Food and Drug Administration) reporting, Risk Assessment, Trending and CAPA (Corrective & Preventive Action).

Performed various boundary tests as well as data validation to ensure record retrieval and search engine tests.

Extensive experience in ALM (Application lifecycle management) and Quality center.

Excellent Knowledge in Leading, Design and Implementation of Quality Management System.

Validation and Execution of Data Migrations (Inter platform block based and file based).

Validation of COTS Software and Vendor Assessment.

Good Knowledge of MS-Project, HP Quality Center and MS Visio.

Excellent communication, writing and interpersonal skills and strong ability to perform as part individually and also as a part of team.

Complete documents and paperwork such as Annual Product Reviews, Standard Operating Procedure training and reviews per FDA guidelines.

Expertise and experience in performing different kinds of testing like Functional Testing, GUI Testing, Backend Testing, Regression Testing, Cross Plat form and Cross Browser Testing.

Education:

Bachelor of Pharmacy from Jawaharlal Nehru Technological University, India- 2010

Technical Skills:

Computer System Validation

21 CFR Part 11 (210/211, 814, 820), GAMP, cGMP, GDP, GLP, IQ, OQ, PQ, RTM, SOPs, Summary Reports, Audit Trails, LIMS, CDMS, Risk Assessment.

Testing Tools

Quality Center, ALM, Clear Quest, Win Runner, ALM.

Business tools

MS Office (Word, Excel, Power Point, Access, Visio), Trackwise 7.0, Siebel CRM, Regulus, Service now, Documentum and GDocs.

Database

MS SQL Server 2008, MS Access, SQL

SDLC

Waterfall, V-Model, Agile

Operating Systems

Windows NT/95/98/2000/XP/Vista/7

Instrumentation

HPLC and FTIR.

PROFESSIONAL EXPERIENCE:

Client: Gilead Sciences- Foster city, CA January 2017 – Present

Role: Technical Writer/ Validation analyst

Responsibilities:

Developed various types of user documentation, including how-to guides, references and comprehensive technical documentation.

Wrote, edited and revised a variety of technical, user documentation such as Web content and manuals.

Designed and authored Standard Operating Procedures (SOP’s) based on the business requirements gathered for Design Specification, User Requirement specification (URS) Functional Requirement specification (FRS), Functional Risk Assessment Validation Protocols like Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).

Review User and Functional Requirement Documents.

Involved in good documentation practice of different stages of validation life cycle in compliance with 21 CFR Part 11.

Creating Requirements Traceability Matrix (RTM) to map the user requirements to the functional requirements, design specification and test script references

Managed documentation on internal portal using Change Control Request (CCR) and SharePoint.

Reviewed processes and workflows, communicated probing questions with business unit, provided gap analysis for process improvements, and verified information to produce high-quality policies and procedures.

Updated Standard Operating Procedures (SOPs) in accordance with FDA audit prep team.

Refine the user requirements to comply with all requirement per 21 CFR 820 and GAMP 5standards.

Responsible for research, planning, production, and on-time delivery of all end-user documentation for software development projects, including release documentation.

Collaborated with executives and subject matter experts during design phase to gain an understanding of the processes used for internal procedures.

Elanco/Eli Lilly - Greenfield, IN February 2016 – January 2017

Sr. Validation analyst- Compliance and IT operations

Responsibilities:

Developing and maintaining deep level understanding of IT processes and SOPs and awareness of business processes for assigned customer area.

Leading efforts to troubleshoot and resolve root causes by applying understanding of the Quality management system and the IT/Business process model.

Leading/setting direction for the implementation of the SDLC processes specific to the customer and the business unit/area’s implementation strategy.

Understanding and interpreting the current direction of technology and its impact on the IT business process model, quality systems, and the organization.

Interacted with the Developers and Subject Matter Experts (SME) to better understand the workflow and functionalities on different modules.

Coordinated with Subject Matter Experts (SME) and assisted in developing Validation Master Plan (VMP).

Assesses Critical to Quality (CTQ) parameters and risk assessment variables as part of the decision making process to support predictable product design, validations, flow, and tech transfers.

Lead Quality Improvement Initiatives; Cost Of Quality (COQ) and Critical To Quality (CTQ) Evaluate quality performance and ensure compliance to quality procedures / processes

Identified and analysed root causes for failures based on test results and recommended solutions with corrective action to Quality Engineering group to initiate CAPA's.

Through focused root cause analysis and effective CAPA, reduced defect rates to a near 6-sigma level at 23 DPPM.

Performs technical troubleshooting on existing processes and products, as required, to advance product development and improve overall performance

Understand the requirements of Data quality and Data Migration

Develop validation deliverables for different GAMP 5 Cat 4 and 5 software applications.

Drafted master validation plan using risk-based approach and GAMP 5 standards to validate the DNC system and point of use software systems.

Migrated the documents Documentum to Regulus.

Monitor the creation, review, and approval of validation deliverables (validation plan, test plan, Requirement and design traceability matrix, validation Report and Test Summary Report).

Understand and interpret quality system policies and procedures, including team-level best practices.

Review, comprehend and assess content within supporting documentation quickly and effectively to comply with the validation strategy.

Processed medical device complaints, risk assessments, conducted investigations, performed impact analysis, CAPA measures, root cause analysis and determination, and produced initial and follow-up MedWatch reports.

Knowledge in implementing compliant and efficient Quality Systems to ISO 9001, FDA 21 CFR 820 for Medical Device developers and manufacturer

Ensured complaint handling tasks were completed as required by company policies and procedures, as well as compliant with applicable industry regulations (e.g. FDA 21 CFR Part 820.198, 803, 806, ISO13485, ISO14971)

Lead the investigations of non-conforming materials through the coordination of cross functional teams while simultaneously performing the role of Quality Engineer.

Facilitated Test Method Validations (TMV) and Measurement System Analysis (MSA).

Trained and advised Quality Engineers on validation concepts, requirements, and techniques (Left after completing projects)

Designed measurement systems for use in design verification, product validation, and process control.

Assists in the Periodic Review of CSQ documentation.

Creating and updating System inventory in service now (new configuration items).

Creating new folders and uploading current working documents in share point.

Facilitates the routing of CSQ documentation produced through the review and approval processes in Regulus, Documentum and Share point.

Wrote IQ, OQ and PQ and developed Data migration protocols and conducted the dry run in HP ALM and Quality center.

Knowledgeable in FDA Regulations for 510(k) and PMA submissions.

Developed Detailed Risk Assessment documentation for managing the risk levels used before validation the system.

Wrote IQ, OQ and PQ and developed Data migration protocols and conducted the dry run in HP ALM and Quality center.

Knowledgeable in FDA Regulations for 510(k) and PMA submissions.

Developed Detailed Risk Assessment documentation for managing the risk levels used before validation the system.

Center for Elders Independence, Oakland, CA December 2014– January 2016

Validation Analyst/Quality Engineer

Responsibilities

Evaluate quality control data, change control requests (CCs) and validation documentation.

Participation in creating Risk Assessment Document.

Data management of performance test results using share point application.

Created issue log and uploaded in to Project share point.

Participated in Validation Life Cycle (VLC) planning, implementation and documentation

Test method validation and PQ protocols for tray sealers, optical stereoscopes, and pouching machines.

Review User and Functional Requirement Documents.

Monitor SPC, CTQ process, DFMEA, PFMEA, control plan documentation and implementation

Implement, maintain, and ensure standard operating procedures and work instructions in work group

Lead multiple cross functional team meetings and assign responsibilities to drive down error and improve efficiency

Develops, implements and monitors the Advance Product Quality Planning (APQP) process and its associated methods/tools, from part/process design through to finalization of the Production Parts Approval Process (PPAP) and release to serial production

Assisted in DFMEA, APQP, PPAP, and R&R implementations. Provided direct support in product design, testing, and validation.

Tracked all deviations and corrective actions as part of test process.

Implemented Good Documentation Practices (GDP) to review and approve the Test Scripts pre execution as well as post approval.

Reviewed Risk Assessment Documentation to check the areas with deficiency, reviewed Corrective and Preventive Action (CAPA) and Preparing Remediation Plans for the project management approval after the GAP Analysis.

Extensive knowledge of HP Quality Center - created, reviewed and generated test management documents, weekly status reports out of HP QC for Business stakeholders.

Prepared Deviation Reports when the test criteria did not meet the acceptance criteria.

Developed Requirements Traceability Matrix (RTM) to map the user requirements to the functional requirements, design specification and test script references

Involved in Complete Software Development Life Cycle Experience (SDLC) from Business Analysis to Development, Testing, Deployment and Documentation

Perform System, Integration, Functional and GUI Testing with ALM Integration.

Worked as SME for selling, OIM (Organization Infrastructure Management) and TPA (Terms and Pricing Agreement) and PMA applications.

Worked and Reviewed the Changes Proposed on the Change Control Management System.

Executed Test scripts developed by other team members.

Participated in User Acceptance Testing (UAT) to make sure that all the user requirements are met and maintained communication with team members.

ALCON, Houston, TX July 2013 to November 2014

Quality Engineer/ Validation Consultant

Responsibilities:

Customized and validated different components of the LIMS modules.

Acquired and documented the business requirements.

Prepared Validation Master Plan (VMP) for validating LIMS.

Performed and managed internal, supplier audits, facilitated external customer and regulatory audits by FDA, notified bodies and responded to audit findings in addition to providing audit reports and corrective actions taken.

Well versed in 21 CFR 820, 210 and 211, ISO 134585 requirements for medical devices, combination and pharmaceutical products for agencies such as CDER, CDRH and MDD.

Assisted in documentation and development of SOP.

Coordinate functional requirements for configuration and document process workflow automation within Share Point, and client systems.

Sigma Projects: Cross Site Contamination Improvement (Defect), End Disk Yield Improvement

Architect of the ProseSixrv LEAN Six Sigma and Operational Excellence Program. Provided training and coordinated Strategy Deployment along with LEAN Assessments to identify high impact projects.

Responsible for analyzing and reviewing validation deliverables like User Requirement specification and Functional Requirement Specification.

Analyzed and reviewed Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ) protocols.

Developed OQ and PQ test cases. Involved in preparation of sanity test scripts. Involved in UAT test execution and raised defects with accurate information. End of the day, report execution status to Test Analyst and Updated regression test suite with recent changes.

Validation activities are performed according to the GAMP V-Model and GAMP5 guidelines.

Providing medical device Quality Assurance technical expertise by participating in the day-to-day operation of the Department as it relates to the design and manufacture of Adiana Permanent Contraception device.

Developed the design verification and validation protocols and reports.

Developed the user patient design requirements for the remediated products.

Created Testing Documentation including Test Plan, Test Cases, Test Scripts, Requirements Traceability Matrix (RTM), Defect Report and Test Summary Report.

Used Quality Management tools such as HPQC to manage requirements, test plan, test scripts and defects.

Managed defects by ensuring that proper documentation and corrective actions have been implemented.

Participated in Defects Resolution process by coordinating with Developer, Application Manager and SME.

Worked with the team in conducting root cause investigations.

Supported manufacturing deviations investigations and the design transfer effort.

Managed the documentations effort through the design control process.

Allergan Inc., Campbell, CA, May 2012 to July 2013

Validation Technician/ Test Analyst

Responsibilities:

Required to support product lines within manufacturing. Supported disposable medical devices Gathered and reviewed user requirements and functional requirements

Designed and authored Standard Operating Procedures (SOP’s) based on the business requirements gathered for Validation Master Plan (VMP) and Validation Protocols like Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ).

Dramatically improved yield, customer satisfaction scores, on-time delivery (OTD) and defect reject rates (DPPM) for Class II and III medical device customers by focusing on customer VOC.

Managed the Supplier Monitoring Process for assigned supply base through DPPM monitoring and Supplier Audit execution. (ISO9001, ISO13485, ISO11137)

Risk management o Strategies and processes for improving quality o Data-driven decision making o Statistical thinking and methods o Lean process.

Used Quality Engineering tools and skill sets including Value Stream Mapping, Lean Manufacturing, Six Sigma, DOE, problem solving – root cause analysis, preventative & corrective action.

Developed and maintained operations metrics dashboard and facilitated quality improvement huddles with process improvement analysts and the management team

Lead daily Gemba- walks to identify lean waste on daily basis.

Wrote Script and documented deviations to qualify Servers and Network Infrastructure Devices(Routers/Switches).

Provide guidance on quality issues that affect the integrity of the data or the system. Independently assess compliance practices and recommend corrective and preventive actions (CAPA).

Performed the GAP Analysis and developed the corresponding Remediation Plan for compliance with FDA regulations

Prepare CAPA plan, write test cases, test scripts, test summary reports for overall product

Traced the validation progress through Validation Assessment Reports

Wrote Validation Protocol for LIMS software to test features like Security /History/Log/ Audit trail

Participated in the preparation of Requirement Traceability matrix (RTM)

Participated in meetings for performing and documenting Risk Assessment, Gap Analysis and creating Remediation Plan

Created, maintained, organized, reviewed, and tracked documents using Documentum Compliance Manager.

DISCOVERY MEDI PHARMA, India September 2010 to March 2012

Validation Analyst/ Quality consultant

Responsibilities:

Developed Design control documents. Adhered to Risk management, and Quality management ISO and FDA guidelines. Followed Design Control requirements (21 CFR 820.30), and ISO 13485

Responsibilities included supporting multiple teams with quality engineering deliverables such as quality planning, risk management (Use, Design and Process FMEAs), process validation, complaint handling and all technical product documentation (manufacturing instructions, drawings, DMR, DHFs, Technical Files, etc.)

Developing Hazard Analysis, FMEAs and V&V activities. Coordinator of corrective action associated with quality projects, including product development and CAPA activities

Develop and execute validation protocols (IQ/OQ/PQ).

Identifies and implements improvement opportunities for established Quality Systems, processes, procedures, and training to support CAPA, Change Control, Deviation, Risk Management, and Investigation processes

Reviewed and modified existing Standard Operating Systems (SOPs) and authored the work Instructions.

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

Engaged in establishing standard quality and validation practices.

Documents storage in Documentum.

Documents storage and creating routing notice in Regulus.

Involved in documenting vendor assessment report from a list of AERS suppliers.

Aurobindo Pharma, India February 2009 to August 2010

Test Engineer/ Validation Analyst (Intern)

Responsibilities:

Prepared documentation for all aspects of the Computer Systems Validation (CSV) lifecycle, in accordance with FDA regulations including 21 CFR Part 11.

Involved in the upgrading of validation Master Plan

Developed and maintained Requirement Traceability Matrix (RTM).

Proficient in writing test scripts and validation/test summary reports.

Developed protocols for IQs, OQs, PQs and detailed test plans for various modules in

Compliance with FDA standards.

Investigate and provide training to drive to root cause for complaints and process failures utilizing quality management and risk-based tools.

Developed supplier quality guidelines and specifications for incoming raw material for R&D in accordance with sector, corporate and regulatory guidelines.

Lead and participated in internal and supplier API, excipient and packaging audits.

Review and participate in QbD FMEA and risk analysis as part of product development teams.

Ensure analytical methods for incoming materials and finished API are compliant with current regulatory requirements.

Quality representative in the improvement and development of new and existing pharmaceutical products and processes.

Developed new product technical transfer process for API materials. Administrator and trainer of electronic documentation and quality management system.

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