Preeti Patel
Summary
Experienced software quality engineer with a strong foundation in quality assurance and testing methodologies. Proficient in utilizing automation tools, bug tracking systems, and test case design to ensure high-quality software delivery. Collaborates effectively with development teams to adapt to evolving project requirements and consistently deliver reliable and efficient software performance. Strong analytical skills and attention to detail ensure successful project execution.
Overview
9
9
years of professional experience
1
1
Certification
Work History
Software Quality Assurance Engineer
Abbott Laboratories
Lake Forest, IL
05.2023 - Current
- Evaluated software development processes and outcomes ensuring alignment with organizational standards and regulations.
- Facilitated verification and validation tasks for computer systems in alignment with new product introductions and software modifications.
- Conducted evaluation and approval of software test case protocols and reports.
- Reviewed and approved action plans for addressing captured issues throughout the development phase.
- Facilitated FMEA, product risk analysis, and formulated strategies to mitigate software-related issues.
- Review deliverables to ensure adherence to established SLC standards.
- Managed approval processes for SLC documentation quality.
- Conduct periodic review of quality systems to ensure the system is in compliant with regulations and fit for its intended use and comply to company policies and procedures
- Support non-product quality computer systems validation by assessing the need for validation and preparing and/or supporting protocols, reports and other documentation as required
- Drive best practices for establishing requirements and completing user and functional verification and validation especially as it relates to user needs
- Collaborated on audit activities and implemented measures ensuring alignment with regulatory guidelines.
- Adhered to applicable FDA, EUMDR, and other regulatory requirements.
- Ensures IT validation packages comply with applicable Corporate and Divisional Policies and procedures
- Works autonomously with related IT contacts and the business process SMEs for quality and compliance
- Coordinates the introduction of new strategic methodologies; supports and approves the overall validation of quality and regulated applications
- Collaborates with the development team to build compliance capabilities in order to assure the quality of the deliverables and ensures business needs are being met
- Execute system retirement/decommission process
- Collaborate on Decommission planning and decommission report
- Applies Good Documentation Practices and assists as appropriate with required documentation for compliance purposes
Software Quality Assurance Engineer
AbbVie Inc
Waukegan, IL
08.2020 - 05.2023
- Monitored and assessed software processes for conformance with corporate guidelines, FDA requirements, and federal regulations.
- Conducted and contributed to diverse reviews, risk assessments, and software quality assurance tasks.
- Served as R&D Quality Agreement liaison with Operations, managing negotiations and documentation.
- Directed collaborative assessments for timely updates to Quality Agreements.
- Assisted in preparing for audits, addressing audit requests, and serving as a subject matter expert resource.
- Ensured agreements met industry standards and AbbVie Quality System requirements.
- Contributed to defining scope of work for seamless cross-functional execution.
- Facilitated information flow across teams, support partners, third-party vendors, and key stakeholders.
- Executed software validation processes aligned with key lifecycle milestones.
- Utilized configuration management methods and documentation standards.
- Demonstrated knowledge of IEEE, SEI, and ISO standards.
- Oversaw task execution while allocating necessary resources efficiently.
- Executed detailed analysis and validation to uphold quality metrics.
- Demonstrated effective skills in both verbal and written communication.
- Applied advanced knowledge of SAP test methodologies alongside proficiency in HP ALM Quality Center.
- Hands-on professional with experience in the software lifecycle (SLC)
- Perform independent review and approval of initial commissioning, decommissioning, qualification (IQ, OQ and PQ) and validation life cycle documents and subsequent changes
- Review and approval of periodic review and re-assessments of qualified systems based on Departmental Validation Master Plans
- Review and approval of retirement/ decommissioning plans, protocols and summary reports
- Review internal documentation and batch records for compliance with regulations and industry guidelines
- Review documents related to quality systems such as SOPs and Master validation plans (Site, Departmental and Functional Areas)
- Contributed to the overall development and maintenance of policies and procedures related to compliance activities
- Reviewed, approved and executed test scripts using HP Quality Center
- Facilitated CAPA discussions by addressing key quality concerns.
- Assist in evaluating vendor contractors when required.
- Involved in detailed audit reviews with stakeholders within internal, external, and vendor frameworks.
Quality Engineer
RCM Technologies (Client: Sarepta Therapeutics)
Andover, MA
05.2019 - 07.2020
- Developed comprehensive policies and procedures for GxP and non-GxP computerized systems, equipment, and networks.
- Authored extensive guidelines for the validation and development of computerized systems.
- Developed comprehensive SOP and workbook for compliance with 21 CFR Part 11 requirements.
- Contributed significantly to evaluating the Lab system's GxP status using the GxP assessment form.
- Performed assessments on the accuracy and compliance of lab equipment interfacing with Labware LIMS.
- Ensured Legacy Systems met regulatory standards outlined in 21 CFR Part 11 during validation tasks.
- Engaged in writing and assessment of URS for a range of lab equipment as part of legacy transition.
- Evaluated laboratory and manufacturing systems to verify adherence to regulatory requirements under 21 CFR Part 11.
- Trained end-users on system usage and regulatory impact of compliant data systems.
- Developed risk-based assessment procedure to classify computerized systems.
- Developed and carried out IQ, OQ, PQ documentation for system validation.
- Created and executed validation plan for GxP systems.
- Created detailed retrospective and revalidation documentation.
- Authored procedural guidelines ensuring consistent qualification of laboratory equipment.
- Established detailed working documents to assist in managing IT changes.
- Developed comprehensive SOP to manage deviation documentation, evaluation processes, approval workflows and implementation tracking within GxP computerized systems.
- Coordinates administrative tasks for CAPA, Investigation, and Deviation systems.
- Collaborated across departments to expedite item closures and ensure on-time resolutions.
- Prepared non-conformance reports after root cause identification using analytical tools.
- Directed establishment of corrective measures and measured their impact.
- Participated in CAPAs to solve manufacturing problems and explain process deviations and change control processes
- Utilized quality tools to implement process flow charting, Pareto analysis and correlation and regression analysis.
- Authored IT Infrastructure Qualification procedure Network Qualification Procedure
- Developed configuration management Procedure and work instructions to carry out the process
- Designed educational materials to enhance employee skillsets.
- Compiled detailed glossary meeting all standard requirements in the quality manual.
- Created guidelines for maintaining documentation quality aligned with FDA and Annex standards.
- Designed periodic review framework for GxP-compliant computerized systems.
- Formulated non-GxP SOPs covering Account Administration, Access Privilege Management, Physical Access, VPN Access and User Threat Investigation Procedures.
Quality Specialist II
ICU Medical
Lake Forest, IL
05.2018 - 05.2019
- Coordinated material compliance in accordance with industry regulations during product change management.
- Managed compliance-related workflows by performing initiation and change analyst activities in PLM IT systems.
- Managed material compliance database within PLM systems for impacted products.
- Manage ASL, vendor/supplier assessments questionnaire, Bill of materials, diagrams, specification control, Risk Assessments, Supplier Audits records, Biocompatibility reports, CME reports Database in PLM system
- Executed gap assessment and addressed deficiencies to maintain compliance.
- Organized current and historical records with precision.
- Conducted regular audits to ensure material compliance.
- Analyzed workflows to enhance operational efficiency through procedure updates.
- Supported efforts for continuous process improvement.
Graduate Assistant
Texas A&M University
Commerce
08.2016 - 05.2018
- Developed comprehensive policies and procedures for GxP and non-GxP computerized systems, equipment, and networks.
- Authored extensive guidelines for the validation and development of computerized systems.
- Developed comprehensive SOP and workbook for compliance with 21 CFR Part 11 requirements.
- Contributed significantly to evaluating the Lab system's GxP status using the GxP assessment form.
- Performed assessments on the accuracy and compliance of lab equipment interfacing with Labware LIMS.
- Ensured Legacy Systems met regulatory standards outlined in 21 CFR Part 11 during validation tasks.
- Engaged in writing and assessment of URS for a range of lab equipment as part of legacy transition.
- Evaluated laboratory and manufacturing systems to verify adherence to regulatory requirements under 21 CFR Part 11.
- Trained end-users on system usage and regulatory impact of compliant data systems.
- Developed risk-based assessment procedure to classify computerized systems.
- Developed and carried out IQ, OQ, PQ documentation for system validation.
- Created and executed validation plan for GxP systems.
- Created detailed retrospective and revalidation documentation.
- Authored procedural guidelines ensuring consistent qualification of laboratory equipment.
- Established detailed working documents to assist in managing IT changes.
- Developed comprehensive SOP to manage deviation documentation, evaluation processes, approval workflows and implementation tracking within GxP computerized systems.
- Coordinates administrative tasks for CAPA, Investigation, and Deviation systems.
- Collaborated across departments to expedite item closures and ensure on-time resolutions.
- Prepared non-conformance reports after root cause identification using analytical tools.
- Directed establishment of corrective measures and measured their impact.
- Participated in CAPAs to solve manufacturing problems and explain process deviations and change control processes
- Utilized quality tools to implement process flow charting, Pareto analysis and correlation and regression analysis.
- Authored IT Infrastructure Qualification procedure Network Qualification Procedure
- Developed configuration management Procedure and work instructions to carry out the process
- Designed educational materials to enhance employee skillsets.
- Compiled detailed glossary meeting all standard requirements in the quality manual.
- Created guidelines for maintaining documentation quality aligned with FDA and Annex standards.
- Designed periodic review framework for GxP-compliant computerized systems.
- Formulated non-GxP SOPs covering Account Administration, Access Privilege Management, Physical Access, VPN Access and User Threat Investigation Procedures.
Education
Master of Science - Biological Sciences
Texas A&M University
Commerce, TX05.2018
Master of Science - Microbiology
Sardar Patel University
India04.2013
Bachelor of Science - Biological Sciences
Sardar Patel University
India03.2009
Skills
- Quality Assurance
- Computer System Validation
- Quality and Regulatory Compliance
- Software Development Lifecycle (SDLC)
- Corrective and Preventive Actions (CAPA)
- Root Cause Analysis
- Gap Analysis and remediation
- Periodic Review
- Quality Audit Support
- Problem-solving Skills
- Results and Deadline-driven
- Test strategy development
- Risk management
- Requirements analysis
- Periodic review of quality systems
- Technical writing
Area Of Expertise
- Extensive experience in Quality Assurance, Equipment Validation, Computer System Validation and technical writing in compliance with FDA standards.
- Experienced in working in a GXP, cGMP, GLP, GCP and GDP environment.
- Excellent understanding of the Software Development Lifecycle (SDLC).
- Expertise in Process validation and qualification of aseptic processes and sterilization processes for the commercial manufacturing through control charting.
- Experience in documenting and reviewing all aspects of the Computer Systems Validation (CSV) lifecycle for Quality Assurance.
- Experienced in collection of User Requirement Specifications (URS) and Functional Requirement Specifications (FRS).
- Expertise in evaluating CSV risk assessments involved in the project in accordance with FDA compliance.
- Expertise in reviewing, modifying and writing standard operating procedures (SOPs), user manuals, validation protocols (IQs, OQs, PQs), validation scripts and maintaining manufacturing batch records.
- Successfully prepared and documented Change Control, Validation Master Plan (VMP), Validation Summary Report (VSR), and Requirement Traceability Matrix.
- Expertise in reviewing and performing and documenting Corrective and Preventive Actions (CAPA), Deviations or non-conformances, Root cause analysis and Change controls.
- Working Knowledge of 21CFR part 11, 50, 56, and 58, 210, 211, 820.
- Experience in system testing, integration testing, regression testing, and data driven testing.
- Experience in writing and executing user acceptance testing (UAT), Functional (Validation) Testing.
- Skillful in carrying out Gap Analysis, performing Remediation Planning and change control procedures for software applications.
- Expertise in designing Testing documents like Test plan, Test design specification, Test cases and Test procedures.
- Experience in system retirement/Decommission process and documentation.
- Strong Analytical, Design and Problem-solving skills.
Certification
- cybersecurity - Security innovation April'2024
Timeline
Software Quality Assurance Engineer
Abbott Laboratories
05.2023 - Current
Software Quality Assurance Engineer
AbbVie Inc
08.2020 - 05.2023
Quality Engineer
RCM Technologies (Client: Sarepta Therapeutics)
05.2019 - 07.2020
Quality Specialist II
ICU Medical
05.2018 - 05.2019
Graduate Assistant
Texas A&M University
08.2016 - 05.2018
Master of Science - Biological Sciences
Texas A&M University
Master of Science - Microbiology
Sardar Patel University
Bachelor of Science - Biological Sciences
Sardar Patel University