Sai Borra

(908) 301-6179
ksai54957@gmail.com

Summary:

 A Seasoned professional with 5 years of Process validation experience in Medical Device industry
with a proven record in validation deliverables, technical writing and testing of medical devices to
ensure safe and high-quality products are manufactured in compliance with global regulatory and
Industry standard regulations
 Professional in conducting Validation practices of equipment process in the packaging line, with
good understanding and implementation of GxP (GMP, GLP, GAMP, GDP) standards, 21 CFR
Part 11, Part 210, 211, 820 and ISO 13485
 Gathered, reviewed and documented Market Requirement to prepare Market Specification (MTS)
and Product Specification (PRS)
 Excellent in understanding and implementing the Quality Management System (ISO 13485, 21
CFR 820, cGMP compliance)
 Clean-in-Place and Clean-Out-of Place cycle development activities for processing tanks, cabinet
washers including parameter selection, recipe design, determining order of operations,
troubleshooting, sampling, and trend data analysis.
 Prepared Quality Risk Management (QRM) for cleaning validations.
 Served as lead executor and facilitated training of two (2) new hires for manufacturing equipment
testing, data interpretation, trending and analysis, and troubleshooting issues.
 Supervised an independent project on introduction of sucrose convey system and management of
activities associated with design of cleaning development and validation activities. Led the root
cause analysis and process improvement initiatives during the execution of the project.
 Involved in successful completion of Benadryl Certification Project for Consent Decree, and
validation activities for Children’s Tylenol and Children’s Motrin suspensions.
 Emphasis in 21 CFR 820.30, Design Control activities- Design Inputs, and Design Outputs,
Validation & Verification, FMEA, Risk Tables, Requirements Traceability, Transfer and Post
Market Surveillance
 Good technical knowledge with expertise in developing DFMEA, PFMEA, UFMEA per ISO
14971
 Developed and updated Master Validation Plan (MVP)
 Experience in the authoring of Process Validation Test Protocols (IQ/OQ/PQ) for related
processes, write/develop Standard Operating Procedures (SOPs)
 Provided training to operators on the new packaging sealer equipment
 Developed technical reports for Risk Assessment, Test Summary, Validation Summary and
maintained Requirements Traceability Matrix (RTM) for various medical devices
 Utilized TrackWise (QMS) software tool to initiate and make Change requests, and to keep track
of applications and reports for CAPA assessment
  Extensive knowledge in the Manufacturing Process Flow, Production Processes, Validation
Strategy, and Validation Methodologies
 Experience in conducting Gauge R&R studies, and Design for Repeatability & Reproducibility
(DFRR) Methodologies and optimized production quality, production yield while minimizing the
product development life cycles
 Excellence in performing calibrations, adjustments, replacement, and repair to process and test
equipment following all applicable safety practices that depend upon accurate metrology
 Higher priority to Quality, Integrity, and Performance of the Medical Device is maintained and
achieved for assigned tasks
 Guided cross-functional teams in the proper application of Design Controls and coordinated with
structural engineers in multiple training activities held for the development of Class I, II and III
Medical devices in terms of design, material, cost and ease of handling

Technical Skills:

Regulations FDA: - 21 CFR Part 11, 21 CFR Part 210, 211, 21 CFR Part 820
(QSR), GAMP 4/5
ISO: - 13485(QMS), 14971(Risk Management)

Validation Deliverables Validation Master Plan (VMP), Test Method Validation (MVP),
Compliance Risk Profile, Compliance Report, RTM, MTS, PRS, IQ,
OQ, PQ Protocols, DFMEA, PFMEA, UFMEA, Design and Change
controls.

Testing tools/software Minitab, TrackWise, SharePoint, ERP, Documentum, AutoCAD,

Business Software Microsoft Office, MS Word, MS Excel, MS PowerPoint, MS Visio,

Professional Experience:

Cardinal Health, Dayton, OH June 2018 – Present

 Performed Cycle development and Initial Validation; COP Validation (Parts-washers) and CIP
Validation (Process Tanks, Filtration Skids, Unicorn Chromatography columns)
 Ensured all validation and qualification activities were consistent with company validation policies
and procedures and federal regulations.
 Created, populated or maintained databases for tracking validation activities, test results, or
validated systems.
 Authored validation protocols for new manufacturing systems, technical memos, protocol
addendums, and, Change Request assessments.
 Prepared validation summary and test method summary reports based on validation data analysis.
 Designed validation study features such as sampling, testing or analytical methodologies.
Performed swab sampling for CIP/SIP.
 Identified deviations from established product or process standards and provide recommendations
for resolving deviations.
 Participated and presented in company meetings related to changes in processes, process
improvement and proper decision making.
 Strong knowledge of metal component production including metal forming, rolling, forging,
extrusion and drawing, milling and sheet metal forming.
 Strong knowledge of plastic component production including extrusion, injection molding, reflow,
and welding.
 Ability to develop, apply, and interpret Geometric Dimensioning and Tolerancing (GD&T) best
practices as per ASME Y14.5-2009
 Experienced in applying design for assembly (DFA) best practices including tolerance stack up
analysis with considerations regarding supplier capability, manufacturing process capability, tool
making variability, material variability, inspection and assembly process variability
 Experienced in applying design for manufacturability (DFM) best practices by reviewing
manufacturing protocol, lot manufacturing record, BOM, tools used and in-line inspections in
production to ensure that designed part can be manufactured with minimum time and cost.
 Strong hypothesis driven experimental design and statistical analysis skills used in verification
and validation testing of the designed components
 Knowledge of FMEA, risk analysis, risk estimation, and risk control used in risk management
planning. Developed/ write Gauge control procedure (GCP) for performing calibration and
preventive maintenance of the gauges mounted onto the equipment
 Initiated both supplier and manufacturer related Nonconforming Material Reports (NCRs) and
provided with complete investigation of the Nonconformance, Root Cause Analysis, and material
disposition of the product
 Provided technical assistance in conducting Failure Analysis for medical devices, mechanical
components, and field returns
 Maintained Risk Management Files for Class I and Class II diagnostic medical device project and
updated with the Risk Analysis and Risk Reports in compliance with ISO 14971
 Worked on CAPA’s collectively with the quality team to perform corrections and implement
corrective actions, and participated in management review meetings as CAPA owner
 Prepared and reviewed Validation Summary Report (VSR) to summarize the overall activity
involved in performing validation of the Single block and Double block digital Dry Bath
configurations
 Responsible for calibrations, adjustments, replacement and repair to process and test equipment
following all applicable safety practices that depend upon accurate metrology
Clinical Innovations, Murray, UT Jan 2016- May 2018
Validation Engineer
 Integrated raw data to assemble, write and issue summary reports according to SOPs for
equipment cleaning validation studies.
 Reviewed documents for data accuracy and control all aspects of documents (Compilation to
Approval and Archival) ensuring overall quality of GMP documentation for the organization.
 Developed and implemented comprehensive templates, checklists according to SOPs for the
validation studies.
 Assisted with the execution and review of Site Acceptance Testing (SAT), Field Acceptance
Testing (FAT) and documentation for newly installed equipment and system
 Supported Quality System development and improvement with respect to the GMP Systems and
Development team compliant to ISO and FDA regulations
 Developed Test plans, Test strategies, Test protocols for validation testing along with the Test
Summary Report (TSR)
 Performed Test Method Validations, including Gage R&R studies and variable Measurement
Systems Analysis (MSA) via Minitab
 Involved in Packaging and Labeling of disposable medical devices
 Performed medical device validation for the Kiwi family of products offering a complete vacuum
delivery system to assist physician during Fetal Delivery of new-born babies
 Analyzed and reviewed Installation Qualification (IQ), Operation Qualification (OQ),
Performance Qualification (PQ) protocols for packaging sealer equipment
 Responsible for writing SOP for the Change control process
 Created and reviewed Design History File (DHF), updated the Design Control Traceability Matrix
(DCTM)
 Performed Gap Analysis, reviewed and approved action plans to ensure compliance during and
after the Design Transfer phase
 Performed Risk Assessment activities through DFMEA, PFMEA and other QA Risk Analysis
techniques to manage potential risk during development and commercialization
 Resolved Technical Issues related to Deviations, Nonconformities in the product and took
necessary Corrective Actions to prevent it from recurring and made sure the quality of the product
is maintained throughout the production and reduce in maintenance, cost, labor, and time were
achieved
 Actively involved in providing training activities to interns on conducting Process Validation
including writing protocols, determining key operating parameters, identifying statistical methods,
and tools when implementing and maintaining Process Validation activities
Relisys Medical Devices Ltd., Hyderabad, India May 2013 - Jun 2015
Validation Analyst
 Implemented line extension of one of company’s products through review and preparation of
design specifications, associated FMEA, tolerance stack up analysis, prototyping, and design
validation plan activities.
 Evaluated impact of line extension on existing suppliers, incoming inspection, manufacturing
process, and Design History File (DHF)/Device Master Record (DMR) documents supporting
design activities.
 Completed regulatory filings to various government bodies Implemented Risk-based management
practices including FMEA, PFMEA to the Product/ Process Development Lifecycle, Product
Design and Development support
 Executed IQ/ OQ/ PQ validation protocols on the processes, and qualified equipment systems and
developed qualification reports documenting the project procedure in line with the regulatory
standards
 Hands on experience in conducting the Validation Tests and analyzing process capability of
various inline processes.
 Managed equipment controls, including scheduling calibration/PM, performing installation
qualifications, and resolving out-of-tolerance issues
 Good at understanding manufacturing documentation including BOM, Assembly Drawings,
Technical specifications and Manufacturing procedures
 Reviewed associated batch records prior to product shipments
 Trained operations staff involved in the packaging line on the completion of product batch records
and trained quality staff on the review of batch records
 Managed and maintained a manufacturing facilities Quality Assurance Program to keep the
operations within compliance and accordance with standard operating procedure and federal
guidelines
 Performed periodic audits of the manufacturing system and applied equipment validation to ensure
the viability of the process
 Expertise in performing GAP Analysis to identify the gaps and generate appropriate
documentation in resolving them

Education:

Master of Science in Mechanical Engineering, Wright State University, Dayton, OH