Test Cases Quality

Satish

Mobile: 678-***-****

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

Summary:

Over 5+ Years of experience in Pharmaceutical, Manufacturing, Computer Systems Validation (CSV) as a Validation Analyst/Quality, compliance analyst/Technical writer/ quality consultant and good understanding of cGxPs (cGMP, GLP, and GCP).

EDUCATION:

Master’s in Computer information system GPA 3.65 (Oct 2015)

Rivier University, New Hampshire

Jawaharlal Nehru Technological University, Hyderabad, Telangana GPA: 3.62 (May 2013)

Under graduation (Bachelors in Pharmacy)

Diploma in Pharmacy:

State Board of Technical Education and Training, India GPA 3.61 (Nov 2009)

Registered Pharmacist with certificate number 07092-PH-014 in Andhra Pradesh Pharmacy Council, Hyderabad, India

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), Risk Assessment Document and 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. 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.

Took part in the verification of different system documents. Ensured that all the documentation follows GDP (Good Documentation Practices). Knowledge on 21CFR Part 11, GxP (GMP, GDP &GLP), GAMP 5 Approach, etc.

ELANCO/ELI LILLY - GREENFIELD, IN FEB 2016- JAN 2017

Validation Analyst/ IT compliance & Quality consultant

Develop/re-engineer and/or implement programs/processes to improve overall compliance and quality in validation operations.

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

Developed Design control documents. Adhered to Risk management, and Quality management ISO and FDA guidelines. Followed Design Control requirements (21 CFR 11,820,210,211)

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

Monitor the creation, review, and approval of validation deliverables (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)).

Ensure compliance of all appropriate validation requirements.

Performs the planning, writing and editing of IT documentation required for compliance with the CSQ policies and applicable departmental guidelines.

Analyzes existing documentation to ensure it meets CSQ criteria. Functions as the point person on the project for documentation advice.

Delivers validation products to project teams as defined in project timelines. Helps organize existing and new documentation.

Assists in the Periodic Review of CSQ documentation.

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 (ALM) and Quality center.

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

Hetero Labs Limited, Hyderabad, India Jan 2013 to May 2014

Hyderabad, India

Validation Analyst

Worked on Global Quality System Legacy Validation initiative, aiming to define and harmonize requirements for the Validation of GxP applications, and to initiate remediation projects for GxP applications, associated to Computerized Systems processes.

Involved in the validation of the following systems: Laboratory Information Management (LIMS) systems, system control and data acquisition systems, electronic Quality Management Systems (eQMSTrackwise), Enterprise Resource Planning systems (ERP) - SAP.

Validation of Adverse Events Reporting Systems (ARISg/Argus), Clinical Data Management Systems.

Quality Management System (QMS), System Development Life Cycle (SDLC), and all associated Standard Operating Procedures (SOPs).

Created validation test plans/scenarios/cases/summary reports, and validation reports.

Validation/test plans, test scenarios/cases/summary reports, Installation Qualifications (IQ), and Operational Qualifications (OQ) for the donor management system.

Ensure compliance with product specifications and FDA regulations, executed system/regression test cases, including the execution of SQL scripts to validate test results.

Preparing test scenarios based on the requirements and then creating Test Cases and Test Scripts.

Conducting/participating Peer Review of Test Plan with the Integration Test team

Software quality assurance, software validation, and dry run of test scripts for Donor Management Information System (DMIS). Dry run of IQ, OQ and PQ test scripts

Managed systems change control and CAPA.

Wrote, reviewed, and approved SOPs, policies, and validation procedures.

AUROBINDO PHARMACEUTICAL LABARATORIES, FEB 2009 – MAR 2011

HYDERABAD, INDIA

VALIDATION ANALYST

Assisted in documentation and development of SOP.

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.

Drafted IQ test cases for verifying configuration.

Developed and reviewed test scripts and test cases for automated and regression testing.

Executed the test cases stored in the Test Plan, imported locally to the Test Lab in HP Quality Center and reported the defects.

Generated Validation Summary Report to summarize and document all validation activities

Developed and reviewed Standard Operating Procedures (SOPs), Requirement Traceability Matrix and Work Instruction for various functionalities of the system.

Used Defect Management grid of Quality Center in logging and analyzing issues.

Analyzed test scripts to check whether all functionalities have been covered within the compliance of 21 CFR Part 11.

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

Proficient with Corrective Action Preventive Action (CAPA) workflow including Investigation, Investigation Task, Action, Request, Request Extension and Closure phases.

Responsible for ensuring the compliance of GMP/GLP and FDA regulations.

Wrote test cases and maintained traceability matrix and wrote the defects in Application life cycle Management tool (ALM)

Performed the Back-End integration testing to ensure data consistency on front-end.

Performed Performance Qualification (Such as Load/Stress, Volume and Response Time) and User Acceptance Tests (UAT) and also documented them.

Graduate Assistantships in Computer Information Sciences Department (Rivier University) September 2014 - October 2015.

Graduate assistantships are paid positions for graduate students which usually involve work as a teaching assistant, research assistant or some other academic assistance to a member of the college.

Assist Professor with research on supply chain practices and strategies.

Responsible for designing the course work and teaching.

Maintaining student’s records and ensuring confidentiality.

Provided assistance with event planning including supervision of undergraduate student workers.

Supervised a computer laboratory.

Assist a faculty member with a research project; engage in literature searches.

Configuration and management of servers used in the delivery of distance courses.

Academic Project: Synthesis and antimicrobial evaluation of 5-Substituted 1 H-Tetrazoles

Completed Academic project on the topic of “Synthesis and antimicrobial evaluation of 5-Substituted 1 H-Tetrazoles”. I selected this project; Developed a simple and efficient method for the synthesis of 5-substituted 1H-tetrazoles using ZnO as the catalyst under mild reaction conditions. This catalyst has been used to generate a diverse range of 5-substituted 1H-tetrazoles of using different nitriles in good to excellent yields. The antimicrobial screening suggests that all the synthesized compounds showed moderate to good activity against the tested organisms.

Technical Skills

Microsoft Family

Worked on two academic projects as part of my curriculum.

Has undergone training programme on instrumental & chemical analysis, during training program worked on HPLC, UV & wet analysis.

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.

Quality Center, ALM, Trackwise 7.0, Siebel CRM, Regulus, Service now, Documentum, Gdocs, Waterfall, V-Model And Agile

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