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Nearly 12 Years of industry experience and 7+ years Software Testing with a solid understanding of Test Planning, Test Design, Test Execution and Defect Reporting & Tracking. Total experience in Manual Testing and Database Testing. Familiar in GxP, 21 CFR Part 11, and Life sciences domain knowledge Expertise in Understanding and Analyzing Test Requirements, Tracking changes and maintenance of Test Requirements. Well acquainted with all phases of SDLC and STLC. Executing Test Cases and reporting defects. Strong Experience in Pharma Domains. Involvement in Test Estimations and Test strategy implementation. Work with project managers, business stakeholders, architects and other development team members to gather requirements. Create documentation in support of development work. Documents may include Functional specifications, Configuration specifications, Workflow diagrams, Installation qualifications, Traceability matrix. Coordinate with product vendors in getting the required assistance. Troubleshoot issues and propose solutions. Actively participate in all the project related meetings and planning activities. Perform configuration in TrackWise Digital Pakages like Platform, Complaints, EQMS, and DMS. Strong experience in creation and update of Salesforce Flows as per business requirements. Installation and configuration of TrackWise components & performing TrackWise version Upgrades and Migration. Responding to support calls for production environment in order to make quick repair to keep Application in production. Good written, communication, interpersonal skills, proven team player with an analytical mind bent to problem solving and delivering solutions. Well-acquainted with the Software Development Life Cycle. Experience in conducting training programs in client places. Strong experience in quality domain with renowned pharmaceutical companies I have played vital role in establishing quality centric image of the company. I have setup quality control systems and procedures and ensured strict enforcement thereof ensure no tolerance culture in quality function. I have strong records of establishing compliance procedures, installations, qualifications, facility creations and calibration of analytical instruments equipment’s& performing tests/inspection procedure in conformance with latest cGMP/cGLP requirements. I have wide experience in handling management of empower electronic data verification, incidents, OOT, OOS investigations and facing regulatory audits [FDA, EDAM, MHRA, WHO, EDQM]
Good Experience in developing LIMS applications of Caliber,Star LIMS,Labware-LIMS.
Good knowledge and of Empower Software.

To build a long-term career in pharmaceutical industries with opportunities for career growth and to solve problems in a creative and effective manner in challenging position

Bachelor of Pharmacy with over 7.5 years of comprehensive experience in Quality Assurance. Proficient in Quality Management Systems, adept at conducting both internal and external audits, and ensuring compliance. Skilled in supplier qualification, equipment qualification, validations, and in-process quality assurance for Small Volume Parenteral (SVP), Large Volume Parenteral (LVP), and Oral Solid Dosage (OSD) and Liquid formulations and Medical Devices. Demonstrated expertise in maintaining rigorous Contract Manufacturing Organization (CMO) documentation standards.

Dedicated and results-oriented Computer System Validation Lead with over 14 years of experience in the pharmaceutical industry. Proven track record of successfully leading validation projects, ensuring compliance with regulatory standards such as FDA, EMA, and GMP. Proficient in developing validation strategies, managing validation teams, and implementing quality systems. Strong expertise in validation protocols, risk assessments, and documentation practices.

Ben Kelley

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CQA Technician

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High School Diploma -

Electrical Engineering

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CQA Technician

High School Diploma -

Electrical Engineering

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