Project Executive

SUMMARY

Over * years of IT QA/CSV experience in Pharmaceutical domain

Experience in leading and guiding the CSV team supporting different projects

Experience in validating the computer systems (COTS & Custom Build) which includes Learning Management System (ISO Train), Quality Management System (Trackwise & ETQ), Custom build applications (Physician Portal, ACARE & Hybris) and ERP (SAP) in compliance with FDA regulations.

Extensive experience in authoring and executing all system qualification documentation including Validation/Test plan, user and Functional Requirements Specification, Test cases/scripts, Requirements Traceability Matrix (RTM) for IQ/OQ/PQ protocols and summary reports with exposure to full Validation Life Cycle.

Knowledge of Equipment qualification, process and cleaning validation

Extensive Experience in authoring/reviewing Change controls, Standard Operating Procedures (SOP), Validation Plan (VP), Risk Assessment and Validation Summary Reports (VSP).

Experienced Data Integrity Specialist

Industrial experience and Good understanding of GAMP5, Annex 11, FDA’s 21 CFR Parts 11, 210, 211 and 820; ICH – Guidelines, GDPR and Form 483 Compliance.

Trained the end users on Data integrity and GxP practices

Good understanding of automated process control systems, clean room and classified area requirements for Aseptic Environment.

Good Knowledge about Waterfall and Agile Scrum Models of SDLC

Expertise in Corrective Action Preventive Action (CAPA) analysis of the project

Involved extensively in Functional testing, System testing, Integration testing & regression testing.

Possesses excellent written and verbal communication skills with strong abilities in requirement capture, analysis, design and development in large application development projects.

Ability to communicate effectively, enthusiastic, self-motivated, and highly organize

Well versed with using JIRA, X-ray, HPALM, Doc-space, Truvault, Solman

Technical Skills

Life Sciences: 21 CFR Part 11, Part 210, Part 211, Annex 11, GAMP V, ICH Guidelines, HIPAA, QMS

Testing tools: HP ALM & X-ray

Technical Writer: Validation Plan, URS, FRS, Trace Matrix, Summary Reports and required Validation Deliverables

SDLC: Proficient in both Agile and Waterfall Methodologies

Project Management: JIRA & MS Project

Professional Experience

TGen Duration: Sep 2019 – Till Date

CSV/IT QA Lead Consultant

Prepare Validation Plan and ensure it is delivered on time without compromising the Quality

Coach teams on FDA regulations specific to software Applications

Establish processes which drive SDLC complying with all the regulations

Implemented Quality Management System which include Change Control management, Deviation and CAPA management.

Author SOP’s and other Validation Deliverables

Perform Regulatory impact assessment and System Level Risk Assessments

Coach the test execution team members on GDP and Data integrity topic

Develop risk based approach for validating various software applications

Review the validation deliverables and provide feedback to team members

Escalate any impediments across the project and provide resolution.

Lead the team members based in off-shore and on-shore

Lead the overall validation process for multiple projects

Lead the validations of custom build applications

GalaxE Solutions (Client: Johnson & Johnson, New Jersey) Duration: Mar 2017 – Aug 2019

CSV/IT QA Lead Consultant

Lead a team of SQA’s supporting different platforms

Provide SME advise & guidance on quality and compliance needs to IT project teams and enable them to achieve compliance using a risk-based approach

Review and approve validation deliverables for GxP projects which includes but not limited to URS, FRS, IQ, OQ, PQ, Trace matrix and summary reports.

Risk assessment of computerized applications

Ensure the application meet all standards of 21CFR PART11, Annex 11 and Data integrity guidelines

Ensure deviations are logged and relevant CAPA’s are taken during the validation process

Ensure defects are managed and resolved appropriately as per the procedures

Ensure the testing methodology is designed on the basis of risk based approach

Train the new joiners on CSV Procedures

Ensure process adherence to software development lifecycle for projects in Waterfall and Agile methodology

Conduct Stage gate assessments for major milestones for the project

Monitor requirements quality and adherence to standards

Assure adherence to change control procedures and guidelines

Ensure tool adherence and data integrity, across various tools –e.g HPALM, Jira

Collaborate with project team on work product evaluations

Generate weekly reports and establish communication with customer on project related activities

Ensure good documentation practice is followed

Ensure Bi directional traceability is established

Hospira, a Pfizer company (India, Vizag) Duration: Jun 2013 – Dec 2015

QA Executive

Responsibilities:

Responsible for planning, executing, coordinating and maintaining validation activities for the GxP impacting Computer Systems in accordance with the regulations

Involved in designing procedures and test methods which comply with business, FDA and industry best practice guidelines: FDA’s 21 CFR 210, 211 and 11; ISO 14971 and 13485, GMP and GAMP 5

Collected and analyzed user requirements and detailed design specifications, functional requirement specifications to develop VP, IOQ’s and risk analysis.

Author validation documents such as OQ and PQ protocols as per the defined validation approach.

Developing and maintaining procedures to regulate changes implementation (Change Control Management) to ensure system compliance through its life cycle.

Reviewed the system related SOPs to ensure compliance of company’s processes, policies, and procedures.

Mylan, UK Duration: Mar 2011 – Jan 2013

Regional Quality Officer

Responsibilities:

Reviewed Corporate, site and departmental SOPs for predicate rules and Part 11 compliance and suggested improvements.

Authored Test cases for LMS.

Involved in installation and configuration (IQ, OQ & PQ) of ISO Train (LMS).

Responsible for reviewing the validated protocols related to ISO Train customized features.

Participated in various business meetings, training for cGMP/ Part 11 refresher, Trackwise, and discussed process improvement issues.

Reviewed and approved product complaints, corrective and preventative action (CAPA) and change controls related to product specifications and deviations

Dr. Reddy’s Laboratories, India Duration: Jun 2008 – Oct 2009

Sr. Executive

Responsibilities:

Perform in-process checks during the manufacturing and packaging of pharmaceuticals

Ensure GMP is followed during the manufacturing process

Ensure the documentation of BMR is done online by production personnel

Document the deviations if any during manufacturing process and investigate it

Ensure all the required SOP’s are followed during the manufacturing process

Train the personnel on GMP

EDUCATION & CERTIFICATION

Bachelors in Pharmacy JNT University, India (June 2004 – May 2008)

MS in Pharmaceutical Sciences Aston University, UK (Oct 2009 – Dec2010)

MS in Computer Science Silicon Valley University, USA (Jan 2016 – Dec2017)

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