Harshkumar Patel Email & Phone Number

Piscataway Township, Nj, Us

Bridgewater, New Jersey, Us

Forchheim, De

➢ Expertise in Test Method Validations (TMVs). Authored and wrote TMV and deviation reports. ➢ Remediated DHF (Design History File) by updating or generating missing documentation and updating DHF Index to reflect most current information. ➢ Prepared and wrote protocols, aided in execution, and reviewed IQ, OQ and PQ ➢ Expertise in all aspects of FDA Regulations, particularly 21 CFR Part 210, 21 CFR Part 211, 21 CFR Part 820, and ISO 13485, ISO 9001, ISO 10993, ISO 14971➢ Supported the development of new products and/or revision of existing products, test method validations (TMVs), FMEA, Risk Management, Design Verification and Validation ➢ Experience working in a Documentation, Quality Management System (QMS), Quality and/or Regulatory environment.➢ Reviewed current Standard Operating Procedures and developed new SOPs. ➢ Led gap analysis and remediation for, SOPs, DHF, Design Input, Design Output, Design Verification, and Design Validation docs. ➢ Involved in Validation Process and preparation of Validation master plan (VMP) ➢ Involved in design characterization activities, reviewing, and approving, risk management activities, and design and process validations. ➢ Superior knowledge of GAMP, GxP’ s (GCP, GLP and GMP), 21-CFR Part 11 regulation of Electronic Records, Electronic Signatures and Audit Trails.➢ Generating Requirements with Risk Assessment, Risk Classification, Compliance Assessments (Part 11, Part 820, GAMP, QSR), Quality Management Processes, Data Integrity, Internal and Project Team Quality/Compliance Audits.➢ Wide understanding working in Orthopedic, Implantable devices, Electromechanical Devices.➢ Expertise in Computer Systems, Laboratory Equipment, Software, Packaging Equipment, Manufacturing Processes and Equip-ment, and Stability Studies.➢ Excellent oral and excellent written communication skills with technical writing expertise. Well versed with MS Office and Pro-ject Management, MS Word, Project, Excel, PowerPoint, Track Wise 8

Surat, In

➢Involved in new project development projects sprouting up. Quality assurance support was necessary to keep up with the schedules. Remediation of existing product lines had to be simultaneously done to keep up with company's and FDA's standards. Customer complaints were also to be handled. ➢Provided quality engineering support to complete FMEA and Test Method validation. ➢Implemented the use of design and process FMEA for design control compliance Led validation, risk analysis and process development for packaging process improvement projects. ➢Developed and Executed Validation life cycle deliverables which include validation plans, requirement specifications, Risk Assessments, test plans, (IQ, OQ, PQ) protocols, Traceability Matrix, and validation reports for HVAC system in compliance with GxP and FDA guideline.➢Provided internal training for QMS functions including organizational training and subject matter expertise for QMS compli-ance and process improvements.➢Documented all the steps in accordance with 21 CFR Part 11, Part 820, and cGMP. ➢Analyzed Test Scripts to be compliant with 21 CFR Part 11 to test the Audit Trail, Data Integrity and Data Security of the application.➢Work with design engineering in the completion of product verification and validation. ➢Executed variable and attribute TMV activities associated with process validation and remediation efforts. ➢Performed remediation activities for Test Method Validation within the Incoming Quality Assurance (IQA) for dimensional checks for both variable and attribute conditions. ➢Performed protocols for design verification, design validation, and aging that met various ISO standards. ➢Led gap analysis and remediation for, SOPs, DHF, Design Input and Output docs., Design Verification, and Design Validation docs., ➢Conducted Design History Files (DHF) gap assessments (audit) and updated the content to satisfy the local SOPs, FDA, ISO 13485, ISO 14971, and corporate quality system.

• Assisted engineers and technicians to develop and implement new test procedure and implement changes to existing test procedures.• Increase the accuracy, production and reduce the error of machines as well as find the error of laser machines and solve the problems.• Completed and distributed documentation records with status reports, material requirement calculations, punch lists, and hydraulic calculations. All information shared with appropriate team members and supervisors.• Collaborated with other mechanical engineers and industrial designers to create and test product prototypes.• Developed drawing packages for assembly following fabrication.• Designed and modeled functions using pre-defined parameters and specifications on specialty machines.• Maintained accurate project records such as updated drawings and documents throughout project life cycle.

Master'S Degree, Mechanical Engineering

Mechanical Enginnering