PROFESSIONAL SUMMARY:

• Pharma Professional with more than 5 years of experience in Medical Device and Quality engineering , ensuring the quality of all products, quality system documentation, manufacturing process quality, and customer problem resolution.
• Expertise in Design Controls, Medical Devices, QMS (Quality Management System) Agile product lifecycle Management, CAPA (Corrective and Preventive Action) Root Cause Analysis and Counter Measures, Complaint investigations, statistical process control program SPC, Knowledge in Risk Management, Supplier Quality, Investigations Technical Writing, Lean Manufacturing Operations, Process Improvement, Lean Quality Tools, Pareto Charts, Fishbone Diagrams, 5S, Control Charts, Process Mapping, Kaizen, Quality Assurance, Change Management, Process/Performance Monitoring, Strategic Planning, Operational Redesign, Verification/Validation, Risk Management, Complaint Management, Confidential and Confidential regulations, Regulatory Compliance.
• Investigated, reviewed and approved Non - Conformance Reports (NCRs), Out of tolerance notices, Corrective and Preventive Actions (CAPAs), Manufacturing Investigation Actions (MIA), and Device History Records (DHF).
• Good Experience using continuous improvement tools, such as FMEA, Root Cause Analysis, in developing the following validation deliverables. - Risk Assessments, Regulatory Assessments, 21 CFR Part 11 Assessments, Gap Analysis documents, Validation Plans, Qualification Protocols, Validation reports, IQ/OQ/PQ, Deviation/Incident Reports, Change Controls and Problem Reports.
• Experience in executing protocols including complex systems such as Computer controlled systems, complex utilities, manufacturing equipment and laboratory equipment.

TECHNICAL SKILLS:

ERP (SAP) and COTS application, Root Cause Analysis, Statistics, Device history record, Process & Test Method Validations, Process Mapping, Investigations,statistical process control program SPC, 21 CFR Part 11, 210, 211, 820, cGxP (cGMP, cGDP, cGLP), GAMP, Validation Plan, Test Plan, IQ, OQ, PQ, RTM, Summary Reports, SDLC, SOP,ECR,DCR, GAP Analysis, Remediation Plans, Audit Trails, Application software s such as Track wise, LIMS, Documentum EDMS,.

PROFESSIONAL EXPERIENCE:

Confidential, Goleta, CA

Packaging/Quality Engineer

Responsibilities:

• Executed validation activities (IQ/OQ/PQ/TMV) and subsequently trained manufacturing team members for validation activities in accordance.
• Involved in developing and filing technical documentation such as Standard Operating procedures (SOP’s) and reviewed various functions of the systems tracking milestones.
• Responsible in creating work orders MTs and evaluated FAIR Reports for Part to print.
• Wrote and implemented ECR (Engineering change request) and DCR (Document control request) by creating redlines based on changes in Revisions from Rev-A to Rev-Y.
• Performed extensive and thorough GDP(Good documentation practices) on several verification documentations by changing, updating and rewriting design verification protocols to ensure Confidential compliance.
• Working on Complaint investigation for CSF and creating memo for DEKRA for all Parts and Accessories, (By using Severity and occurrence rate from FMEA).
• Involved in working with Internal Company Audit in JAN 14th 2019 for DEKRA.
• Worked on investigations on dimensions failure and length failure for CFS.
• Reviewing Risk management documentation from agile and Preparing RMF based on complaints List (RMF-0010, RMF-0019 For catheters and CSF strata valves).
• Created protocol and summary report of Test Method Validation (TMV) for various inspecting methods.
• Working on DHR Device history record, Reviewing the DHR files and Making redline changes if necessary.
• Provide guidance and direction NC Observations and CAPA investigations. Complete NCOs, CAPAs as required to enhance the QMS
• Effectively manage and improve the CAPA process and system for tracking, trending & reporting
• Redlined and updated IFU based on change plan and closely worked with the Tech writers and Routed in agile by gathering and attaching required documents for ECR.
• Establish a standard set of requirements for Design History Files (DHFs) created and maintained in the Agile PLM System for catheters, delta, Ti-Mesh, clip-Guns.
• DHF is created to contain the design records associated with the design history of a finished device. The deliverables for the DHF change control.
• Good Knowledge on SPC like (e.g., plotting, recognizing out-of-control points, etc.)
• Conducting remediation for the verification and validation results in order to make sure all the evidences are recorded and stored according to Good Documentation Practices.
• Supported Packaging implementation team for labelling changes and updated BOM Reports (Bill of Material) with New ECR and updated in Agile.
• Made note of any issues during the process and testing phase and worked with product development to resolve to assure high quality deliverable to customer.
• Closely worked with the IQC and production team for Fair memos.
• Participate and facilitate product and process risk assessments with Failure Mode & Effects Analysis (FMEA).
• Additional work included Process Validation involving FMEA's, Risk Analysis and Sampling Plans, created cost saving sampling plans to support various validation activities.
• Updated occurrences rate in risk documents (pFMEA/dFMEA) as part of annual risk review based on the results of annual metrics.
• Created RMF memos (Risk management files) to DEKRA, and updated occurrences and severity rate based on complaint history.
• Prepared documented procedures of the validation life cycle to ensure compliance with Confidential regulations, including 21 CFR Part 1.
• Involved in GAP analysis for the verification of user requirements documentation.
• Authored and reviewed user manuals and summary reports.
• Updated support documents for utilizing the functionalities of the equipment and support.
• Maintaining an overall SPC system that is used for product release.
• Documented subsequent updates to the validated functionalities in a maintenance plan.
• Conduct GAP Analysis and prepared Remediation Plans.

Confidential

Packaging Engineer

Responsibilities:

• Worked on Equipment Qualification activities like IQ, OQ and PQ for manufacturing and storage equipment including URS, FAT, Temperature and Humidity mapping studies (Kaye Validator).
• Authored and executed Installation Qualification (IQ) and Operational Qualification (OQ) protocols for equipment including HPLC, GC, Autoclave, Spectrometer and another laboratory equipment.
• Worked on validation activities, including planning, characterizing, statistical sampling plans, Gage
• R&R,PFME,generation,confidence/reliabilityevaluation(riskmanagement), process equivalency evaluations (Minitab), data normality analysis, IQ/OQ/PQ execution and deviation remediation / mitigation, and CpK/PpK analyses of manual, semi-automatic and fully automatic (PLC-controlled) manufacturing processes
• Experience in validation Installation/Operation/Performance Qualifications (IQ/OQ/PQ) for equipment used in the manufacturing of medical devices.
• Created protocol and summary report of Test Method Validation (TMV) for various inspecting methods.
• Ability to apply Gage R&R and statistical tools towards validation and evaluation of measurement methods.
• Developed Failure Mode Effects Analysis (FMEA), Risk Analysis, and Master Validation Plan (MVP).
• Participated in CAPA meetings and activities, helped to identify the root causes of the manufacturing problems.
• Conducting weekly design reviews with the manufacturing and the cross-functional teams solving gaps in the remediated documents relevant to specific Design History Files (DHF).
• Perform searches, generate reports, and analyze control charts and data trends using Minitab for Non-Conformance Report (NCR) systems.
• Experience with root cause analysis and some risk assessment tools (DMAIC, fishbone) via investigative work.
• Participated in devising ways to effectively implement the principles of Lean and support a culture of continuous improvement.
• Develop adequate sampling plans, inspection procedures, and test methods to maintain product performance and meet long term manufacturing goals (yield/scrap, acceptance sampling, etc.).
• Maintained positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
• Created the Master Test Plan to define the test strategy based on functional risk assessment and define the list of required IQ/OQ/PQ test scripts.
• Defined the deviations and proposed Corrective and Preventive actions during test execution phase.

Confidential

Quality Engineer

Responsibilities:

• Reviews production batch records and associated data for product release. Determines if records are within range of cGMP regulations. Reviews data obtained for compliance specifications and report abnormalities.
• Identifies, classifies and reports deviations, as appropriate and typically works on Minor, less complex deviations.
• Oversees execution of remediation/CAPA activities required to continue production or move a process to the next milestone. Works closely with cross functional team members to determine root cause and potential preventative/corrective actions.
• Ensures support for the timely closure of investigations. Authorized to suspend any operation when the situation warrants and immediately notify Quality Management.
• Provides guidance and control directives regarding remediation activities required to continue production. Is required to escalate critical issues within area assigned to senior management team based on severity of the issue.
• Quantify and identify presence of non- routine, unusual or esoteric compounds or target compounds by using technology like Gas Chromatography Mass Spectrometry (GCMS), High Pressure Chromatography.
• Prepare Standards, management of samples before and after analysis, controlling flow of work, generate & review data reports by following the guidelines of EPA & State Agencies.
• Follow official test methods and laboratory Standard Operation Procedures.
• Performs independent technical review of documentation during and post-execution of cGMP activities. Ensures all specifications are met and that applicable requirements are completed and acceptable.
• Ensures all issues/documentation associated with each process in assigned area have been resolved prior to release to the next step and are compliant with cGMPs and SOPs and current manufacturing regulations and site procedures. Analyzes and reports findings internally and to appropriate departments.