Pavan Raj

ac8g9n@r.postjobfree.com

626-***-****

•Experienced Quality Engineer in handling projects in upgrading lab, Method development, Method transfer and Method validation. Experienced in Quality Systems like Change Control, OOS & OOT investigations and CAPA.

•Continue to excel in the Quality Assurance field using current knowledge of systems, applicable standards, and technical experience to drive continuous improvement for delivery of quality, compliant products on time, and demonstrating excellent customer satisfaction.

•Hands on experience in writing and developing SOPs, quality and validation training modules, deviations, CAPAs, UAT, URS, FRS, and VMPs. Hands on experience in TrackWise, Documentum, Cleaning Validation, Process Simplification, ISO 9000 Implementation, Deviations, CAPA Investigations, writing and executing IQ/OQ/PQ/PV protocols, VMP development for finished products, Supplier and Internal Audits, Steam Sterilization, Filling Process Validation, Vial/Capping Validation, Packaging Process Validation, Labeling Process Validations, Autoclave Validation, HVAC System, Validation, Thermal Mapping, SOP development, and Site Validation.Involved in Process Validation and Test Method Validation.

•Research & apply advanced technologies. Lead & execute defined strategies through integrated approach, lean methodology (DMAVV, DMAIC, RCA, VSM), statistical & predictive software, supplier networking, RFP, RFQ, SAT, FAT, facility layout. Equipment refurbish, commissioning. Validation & transfer of new technology

•Stress, DFMA, DFSS, FEA (Strudl, Nastran, Ansys), Tool Design (fixture, gauge, dies, plastic injection mold)

•Support development, manufacturing transfer of new products from concept, PMA to commercial launch.

•Lead cross-functional development teams; technical and feasible evaluation of new technologies.

•Leadership experience, Design Controls and Risk Management, Design Verification & Validations, Post Market Surveillance; Working knowledge of FDA regulations, QSR, ISO, 21 CFR Part 820, ISO 14001.

•Authored and created dossier content from source documentation as needed for module registrations and provide writing support for technical reports and global regulatory strategies.

•Extensive knowledge in Problem Solving skills, lean manufacturing, Minitab, Six Sigma Quality Tools, Project Management, DFMEA, PFMEA, Gage R&R, DOE, IQ/OQ/PQ, MRB, CRB, DMAIC, Sampling Plans, Complaint Investigation, MDRs, Vigilant Reports, CAPA & Complaint Handling.

•Re-designing automated and manual Electrical-Mechanical fixtures (software & hardware).

•Participated in the creation of manufacturing risk documents (DFMEAs, PFMEAs) by assessing severity-probability of failure modes and controls to detect and prevent them.

•Lead equipment development and evaluation. Execute process automation, IQ/OQ/PQ, proof-of-concepts.

•Define & develop pharmaceutical processing & packaging. Design evaluation / mitigation per 14971, error prevention, mistake proofing, reducing variation & defects. Define process metrics, test measurement, CTQ, DFMEA, PFMEA, Process Validation & Remediation. Review protocols, CCB docs

•Well versed with SPC, DOE, GMP, PDM, Software validation, Statgraphs, SAP, Minitab, MS Excel, Word, Visio & Project, GD&T, Solidworks, Unigraphics, AutoCad, Catia

EDUCATION

Bachelor of Science in Electrical Engineering, Jawaharlal Nehru Technological University, Telangana

Experience:

Zimmer - Memphis, Tennessee December 2016 to Present

Validation Engineer

•Review and approve Validation protocols (IQ, OQ, and PQ) based on Risk and statistical measurements such as process capabilities (Cpk. Ppk), confidence intervals and reliability.

•Performed multiple attribute and variable Test Method Validation Execution activities for the test equipment in Returned Products lab.

•Wrote test methods for existing work instructions and developed strategies to validate them (TMV).

•Developed and executed IQ, OQ and PQ protocols for product, processes and equipment within the facility.

•Worked on Design improvement & optimization and study of feasibility of manufacturing.

•Authored, reviewed and approved Test methods / Test Method Validation Protocols and Reports

•Design test equipment and fixtures to facilitate manufacturing processes and to achieve product performance expectations.

•Optimize designs for production using DFA /DFM principles.

•Create time line for each project, prepare project reports, and present to management.

•Evaluated test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives

•Developed functional Test Methods for design verification, process characterization, process validation, and finished product

•Validation and Verification Activities for Medical devices and Packaging- Performed assessments on previously validated process validation documents.

•Writing protocols and executing them for various studies in support of worldwide Regulatory submissions.

•Directing the Test Method Validation activities by performing Tooling qualification on equipment.

•Performing statistical analysis on the test results for checking normality, using statistical software like Minitab, Stat-graphics, and Excel.

•Statistics Process Control to comply with International, Standard such as ISO 13485. Performed Process development, and packaging validation review per ISO 11607. Process Capability of packaging and qualifying the manufacturing equipment’s.

•Validated test methods for Tyvek tray and pouch seal testing and did feasibility testing to understand the test parameters. Performed statistical analysis of the test results.

•Wrote and revised SQP's, labeling review, and document review prior shipping. Protocol Writing and Execution:

•Developed and maintained validation documents for the project. Design validation plans and supervise execution of plans. Report validation tasks on validation summary reports. Performed TMV (Test Method Validation) protocol document development in a fast track environment.

•Quality Management Systems. Develops and implements corrective/preventative action plans. IQ, OQ, for Remediation Plan. Identified revalidation requirement on basis of systems changes. Manage adherence with 21 CFR Part 11 for assigned validation consultancy systems.

•Design controls: performed design of experiments, new product introduction process; FMEA’s, GR&R, specification development, generated ECO’s, and performed validation/ verification. Improve the Corporate Quality System in the area of Statistical Analysis application for DV&V and PV&V, Test Method Validation (MSA), Risk Management per ISO14971 including FMEA. Integration of process control into product development during product design.

•Quality Management Systems. Designed test fixtures using Solid works, developed test methods, and executed gage R&R methods.

•Performed assessment audits of systems creating gap analysis - comparing ISO 9001 QMS to ISO13485. Up-dated systems incorporating ISO13485 elements established DMR and DHF, upgraded change control (ECR/ECO) process. Wrote/rewrote procedures, inspection instructions.

•Implemented process controls for product and process improvements. Supported Inspection, 1st Article, In-Process- BOM's-WIP, Tests and MRB. Created data collection methods and statistical process control (SPC), Cpk, parato, yield, and trending reporting.

Hindustan Surgical- Hyderabad, India March 2014 to April 2016

Validation Enigneer

•Performed Test validations procedures, for dialysis machinery. Generate and execute validation test protocols and testing's. Conducted CAPA, continuous improvement, audit, quality systems and assurance, etc.

•Developed supplier production parts by utilizing GR&R, Process Quality Control using SPC, Test Method Validation (TMV), Process Validation (IQ/OQ/PQ), Process Capability study, and First Article Inspection.

•Working on Critical activities like labeling subsystem requirements update, Event Based Risk Review, Label content approval, labeling verification Report, Instructions for Use study, Trace matrix update, RACT update & DHF index update etc.

•Performed packaging verification testing for sterile barrier system and protective packaging. Biocompatibility testing and shipping related packaging testings.

•Interacted with supplier for failure analysis report for components such as Supplier Corrective Action report as part of NCR and CAPA system.

•Provided effective support in all the stages of engineering design change process and document control. UDI project to change renal product labels to meet GS1 standards using change control process

•Resolve manufacturing quality issues and Non-conformance (NCMR) investigations within CAPA system, Quality hold & MRB, Process Validation (IQ/OQ/PQ), Supplier Quality (PPAP), GR&R, Statistical Analysis, Quality System Improvement as part of remediation activity, Design Control, DFMEA/PFMEA, Process Control Plan per APQP, Test Method Validation (TMV), and FDA and NSAI audit participation.

•Detailed & complex analyses & tests requirements, FRS, performed test cases for research, and development. Executed Validation data analysis, reports, and recommendations for changes and/or improvements. Created test methods and fixtures for destructive strength tests.

•Developed and executed protocols for package design, packaging processes validation and package shelf life testing. Write protocols, perform studies, and evaluate the protocol test results, in accordance with 21CFR part 11

•Responsible for ensuring adherence to the regulatory and procedural requirements that govern those operations and products. Integrates Quality Systems and Regulations.

•Verify and approve; Change Control, Investigations (NCR's), Validation Protocols. Promote process control through activities in support of equipment and process validations. These activities are primarily product checks that support or refute validation studies.

•Monitor processes through the implementation of World Class Manufacturing Strategies, including Statistical Process Control (SPC). Responsible for generating and interpreting SPC control charts, technical reports.

Abbott India Ltd, Mumbai, India July 2012 to January 2014

Validation Engineer

•Extensive experience on Test Method Validation (TMV) for analytical, attribute and variable measurements. Write and review process validation plans. Execute the required pre and post-approval qualifications for the Abbott Molecular (AM) Division's Laboratory equipment, Utilities, Facility Processes, Cleaning Processes, new Laboratory and Manufacturing Facility start-ups, and Test Methods that require cGMP compliance.

•Involve in ECO, DHF, DHR, FMEA, DMR, Compliance, QSR regulations, project management, Corrective Actions and Preventive Actions. Correspond with Regulatory and audit team. Train to Design Control AAMI.

•Developed in-house electropolishing process utilizing DOE methods. Managed feasibility and design verification builds. Organized and executed design verification phase. Operated SEM, SmartScope, and Fatigue Tester to aid in R&D investigations and testing.

•Validated the packaging equipment for pouch sealer and trays sealers. Qualified equipment’s like sealing bars.

•Develop SOPs and other program-defining documents.

•Wrote, Drafted and developed Validation IQ/OQ/PQ/PV Protocols to be executed, and provide secondary review of Validations and Qualification Protocols. Responsible for Risk Evaluations, Field Actions, and Investigate Level III and Exceptions.

•Provide secondary review of experimental data and disposition test results. Investigate and correct CAPA findings, IQ/OQ/PQ validation protocols for internal audits and Out of Specification (OOS) test results.

•Audit and review the calibration, PM, EUF CAPAs and test method and process documentations, and identification of Quality Assurance corrective actions required to resolve Quality Assurance issues. Provide technical knowledge and support to help accomplish the Abbott Molecular business goals.

•Write validation documents for Phase I, II and III projects for total parenteral nutrition (TPN) products, In Vitro Diagnostic Devices (IVDs), stability protocols, new drugs validation protocols, new lab start-ups, and lab equipment validations.

•Implement FDA, 21 CFR, OSHA, EPA, EMEA and other regulatory related regulation requirements including departmental System Functional Specifications, validation plans, SOQ, IQ/OQ/PQ/PV validations, execution computer system validations, and write validation reports.

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