GARIMA THAPA
Apex,NC
Summary
Results-driven Validation/Quality Engineer with extensive experience in the Pharmaceutical Industry, specializing in the development, review, and approval of technical packages including URS and SOPs. Proven expertise in validation and qualification documentation such as IQ, OQ, PQ, and PV, coupled with a strong foundation in statistical methods like FMEA and Risk Management. Adept at implementing GAMP5 compliance requirements and skilled in Change Control, CAPA, and Good Documentation Practices. Committed to advancing regulatory compliance while enhancing product quality through meticulous validation testing using industry-standard tools.
Overview
10
10
years of professional experience
Work History
Engineering Verification Manager
Pfizer
Sanford, North Carolina
05.2023 - Current
- Oversaw the verification and validation of diverse systems, including process equipment and control systems for major projects surpassing $250,000.
- Supervised a team of verification specialists, providing guidance and training on best practices related to data validation.
- Support system audit trails, data integrity, and alarm management requirements.
- Conducted comprehensive review of verification documentation.
- Support regulatory audits and BLA filing.
- Conduct SME impact assessment on change control.
QA Validation Manager
Pfizer
Sanford, North Carolina
01.2022 - 05.2023
- QA validation lead for capital and non-capital projects, including but not limited to – validation master plan (process validation, cleaning validation, equipment validation, computer system validation), impact assessments, review, and approval of qualification/validation protocols, and summary reports.
- Performed gap analysis, process mapping, and remediation activities for process validation and CSV projects.
- Completed a detailed assessment for the periodic review audit risk assessment for CSV, and actively participated in monthly DI meetings, and presented awareness training regarding data integrity practices.
- Quality lead on the risk management process, PFMEA, and mitigation controls for multiple commercial vaccine and gene therapy projects.
- Applied a systematic approach to problem-solving and process improvement using quality management and engineering tools such as Six Sigma, DMAIC, Statistical Process Control, and DOE.
- Aligned the site procedure with the BOH regulations for applicability to the commercial and clinical environment.
- Trained and mentored associates and contractors in validation principles.
Sr. QA Validation Associate
Pfizer
Sanford, North Carolina
05.2020 - 01.2022
- Reviewed validation documents (including, but not limited to, design review, URS, FRS, IQ, OQ, PQ, process validation, and cleaning validation), calibration certificates, and equipment/room certifications.
- Support internal and external audits, and ensure compliance with GMP and company-specific procedures.
- Supported quality management system, CAPA system, investigation reports (IRs), temporary change requests (TCRs), and non-conformance report (NCR).
- Improved work methods by analyzing methods and procedures to ascertain the most efficient way to perform the tasks.
- (Developing work instructions to streamline training on data analysis.)
Validation Engineer
Pfizer
Rocky Mount, North Carolina
08.2018 - 05.2020
- Validation Lead for the execution of the remediation project (WET LOAD, Aseptic Sterilizer Improvement).
- Improved work methods by analyzing methods and procedures to ascertain the most efficient way to perform the tasks
- Implemented Ellab verification and streamlined SOPs and protocols for control temperature mapping.
- Coordinated with Technical Sterility, biological/chemical quality, Production, and Quality to complete the Risk Assessment for requalification and wet load.
- Authored and executed qualification protocols and summary reports for aseptic sterilizers, terminal sterilizers, isolators, depyrogenation ovens, controlled temperature units, computer system validation, and enterprise systems upgrades.
- Performed a periodic review on equipment, facility, utility, sterilizers, isolators, depyrogenation oven, controlled temperature units, computer system, and automated process control, which includes protocol preparation, scheduling, protocol execution, analyzing data, and composing a final report.
- Assisted the lead engineer and regulatory group in filing CBE30 and other regulatory submissions.
- Guided Associate Engineers and/or Technicians with their assigned projects.
- Systems used: Minitab, PDOCs, Track-wise, ValSuite, Kaye AVS system, Kaye Validator, thermocouples, Ellabs, and temperature measuring devices (Temptale).
Quality Engineer (contract Role)
Inn Focus INC, Santen Pharmaceutical
Miami, FL
05.2018 - 07.2018
- Performed gap assessments, conducted non-conformance investigations, and implemented the CAPA system for the packaging failure project.
- Performed supplier qualification, supplier audits, supplier performance analysis, and trending.
- Updated the operating procedures for the manufacturing of IMS to be compliant with GMP.
- Assisted Sr. QA Engineers in performing the process validation, test method validation, design validation, and verification.
Validation Engineer
Cytovance Biologics
Oklahoma City, OK
07.2015 - 04.2018
- Authored and executed validation protocols, test scripts, and summary reports (IQ/OQ/PQ).
- Performed qualification testing on the GE AKTA Ready Chromatography Skid using Unicorn Software.
- Performed CTU qualification, thermal mapping, column installation and qualification, and qualified automation systems by following approved SOPs, cGMPs, and ICH guidelines.
- Coordinated and assisted contracted personnel through the completion of the autoclave sterilization process, cleaning validation, and HVAC qualification.
- Helped with the design and execution of computer system validation (CSV), covering multiple computer and software platforms such as Empower and Softmax Pro, and ensured all new and existing electronic and/or computerized systems complied with the regulatory requirements.
- Assisted in the completion of the Process Validation project for a phase III client.
- Provided a quality review of equipment qualification protocols and reports, equipment change controls, calibration reports, and preventative maintenance reports.
- Worked closely with the investigation team to complete investigations related to validation activities and provided day-to-day guidance and training to other validation technicians.
Education
Master certificate in Advanced Management -
Babson College
03.2024
Bachelor - Molecular biology, Chemistry
East central University
Ada, OK12.2015
Skills
- Risk assessment proficiency
- Quality assurance expertise
- Communication
- Process improvement strategies
- Continuous improvement mindset
- Change management experience
- Regulatory compliance
- Verification methodologies
- Team leadership qualities
- Cross-functional team leadership
Timeline
Engineering Verification Manager
Pfizer
05.2023 - Current
QA Validation Manager
Pfizer
01.2022 - 05.2023
Sr. QA Validation Associate
Pfizer
05.2020 - 01.2022
Validation Engineer
Pfizer
08.2018 - 05.2020
Quality Engineer (contract Role)
Inn Focus INC, Santen Pharmaceutical
05.2018 - 07.2018
Validation Engineer
Cytovance Biologics
07.2015 - 04.2018
Master certificate in Advanced Management -
Babson College
Bachelor - Molecular biology, Chemistry
East central University