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Quality Engineer Project

The Villages, FL
June 07, 2019

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Jagdish Vyas

***** ********* **** ***

Windermere, FL 34786



Over 20 years’ of manufacturing experience in Pharmaceutical and Medical Device industry with various validation/Quality/GMP/Quality audit (internal/external supplier), CAPA, complaint (investigation/root cause/trending), gap analysis, IQ/OQ/PQ/TMV/cleaning validation, protocols, testing procedures, work instruction, SOPs, Risk Management (pFMEA/dFMEA), document change control and generation of final reports.

FDA regulations - 21 CFR 11, 210, 211, 820, GMP, GLP, QSR, QMS, ISO 9001, ISO 13485. ISO14971.


Edgewell Personal Care / Playtex LLC, Ormond Beach, FL

October 2018 – May 9, 2019


Participated and acted as quality representative to new supplier selection process as well as existing supplier performance improvement team. Provided quality input via interacting with cross functional team and departments such as purchasing, product development, lab, product development and manufacturing. Reviewed supplier performance on quarterly basis per part accept/reject data and trending analysis. Performed supplier audit to ensure supplier part manufacturing process controls in compliance with quality standards and documentations (IQ, OQ, PQ, Gage R&R, procedure, work instructions, training, PM schedule, calibration schedule). Initiated as required SCAR, worked with supplier to review and approve supplier investigation, corrective and preventive action plan.

Remediated and updated supplier file, Approved Supplier List (ASL) per internal and external audit findings and worked with receiving team to revise material inspection, sampling plan, measuring techniques. Participated in Material Review Board to ensure Coordination of MRB activities with the business unit to ensure the timely assessment of potential non-conforming products. Liaising with the Manufacturing, purchasing, product development, packaging Quality groups, in assessing and addressing material quality issues with assigned suppliers. Responsible for supplier quality performance assessment and measurement including KPI’s and reporting of metrics for quarterly reviews

Responsible for initiating, executing, reviewing, approving change controls, deviation, CAPA, complaints analysis, risk management, and validation.

Performed numbers of deviations / CAPA root cause investigation, corrective action, preventive action related to equipment, process, product, raw materials, packaging components, in-process / finished product out of specification, and incoming inspection. Developed action plan and timelines for past due deviations / CAPA remediation project to minimize back log.

Acted as validation team leader for ongoing and new validation projects. Initiated, executed, validation documents such as IQ/OQ/PQ, TMV, Gage R&R, SV, and cleaning validation. Responsible for reviewing, updating, and approving training matrix, SOPs, work instructions.

Reviewed and updated supplier file per Approved Supplier List and performed gap analysis. Develop action items for supplier related issues, corrective action, and timelines.

Reviewed and approved skin care formulation / specification including variable SPF level product family, lotion, and aerosol product line. Responsible for updating the Risk Management files with the Post Market Surveillance Reports findings for the legacy products.

Responsible for multi-tasking functions of reviewing and approving, product specifications, procedures, part specifications, change controls, BOMs, complaints analysis, risk analysis, SOPs, Work Instructions, quality inspection plan,

Managed validation timeline for new and existing validation projects, as wells as new Aerosol project.

Developed and updated material inspection plan. Actively participated production meeting to provide quality input. Provided monthly and quarterly quality report to upper management. Managed and reviewed data and performed data analysis.

Zimmer/Biomet, Warsaw, IN, Palm Beach Gardens, FL, Statesville, NC

July 2017 - August 2018 (July 2008 to May 2009)


Provided quality input to review and approve supplier sampling and inspection plan to ensure quality standard. Updated and revised supplier qualification procedure for selection process improvement. Ownership for supplier quality performance and measurement including KPI’s and participate in supplier performance reviews. Enable reporting of metrics for monthly reviews. Worked with suppliers on quality related issues for effective supplier containment and corrections/corrective actions via SCAR root cause and investigation. Participate in External Audits and Internal Audits as needed. Responsible for accuracy and integrity of supplier data that ensures compliance with documented procedures & processes.

Participate in the supplier material related processes which include: Material Review Board to ensure Coordination of MRB activities with the business unit to ensure the timely assessment of potential non-conforming products.

Responsible for remediating Risk Management project, design V&V project, CAPA investigation team, complaint review and risk analysis.

Responsible for developing, executing, reviewing, and approving work instructions, procedures, quality inspection plan, IQ/OQ/PQ/TMV protocols and reports. Involved with CAPA team and complaint handling team to provide quality support for initiation, investigation, root cause, complaints investigation and closure, change control request, drawing updates, and gap analysis to current QMS.

Developed quality inspection plan for manufacturing materials, incoming parts, and sampling requirements.

Created new and Updated existing work instructions, procedures, and specifications.

Interacted and provided cross functional team support for supplier qualification working with purchasing team, manufacturing process improvement project team, product development for design V&V and DHF remediation projects.

Worked with product development team to support design verification, remediated DHF per gap analysis.

Developed and executed IQ for sterilization Gamma Radiation Validation.

Remediated cleaning validation and verification protocol to add new parts based equivalent material type, and cleaning surface area.

Created Powder Recovery System (PRS) PFMEA, work instruction document.

Worked with packaging to revised drawing for Gamma Radiation Sterilization Indicator.

Depuy Synthes (J&J), Palm Beach Gardens, FL

September 2013 – June 2017


Reviewed and updated fifty-six (56) suppliers file for completeness per quality standards, performed gap analysis and develop action items for audit and improvement. Worked with incoming receiving team to develop quality inspection plan and sampling plan. Initiated multiple SCAR per audit finding.

Reviewed and revised risk documents as required in working with cross functional teams such Product Development, Manufacturing and Packaging Engineering. Revised DCRM (Design Controls Risk Management) / PRM (Process Risk Management).

Responsible for Non-conformance (NC) and CAPA initiation, root cause and investigation and closure, worked on numbers of CAPA and NCs, in some cases worked with CAPA board for escalation. Involved with CAPA Effective Monitoring (EM) action and report. ETQ software was utilized ETQ software CAPA actions, and Cognos was used for NC related search.

Reviewed closed CAPA to perform gap analysis, developed action plan and timeline for remediation

Updated validation procedures and MVP initiated and executed high numbers of IQ/OQ/PQ/TMV/gage R&R protocols and final report. All protocol and reports were approved and released by initiating and releasing through change Order Controls (CO) via software Document Locator (DL) / windchill.

Initiated and executed numbers of Inspection Plan (IP) / Inspection Feature Plan (IFA) documents for production support.

Developed and released tooling specifications for Inspection Measurements Test Equipment (IMTE) and established calibration criteria. Worked with calibration team for calibration scheduling and timelines.

Performed gap analysis and resolved by creating and implementing action plan. In addition, interacted and participated with supplier team in reviewing and revising supplier related issues (rejects/ defect) to minimize nonconformance.

Provided quality input and support to Product Development project such as DHRC, DHR, Design V&V (Verification & validation), Gap Analysis, complaint analysis report for risk identification, required procedures revision and implementation, work with external supplier for design input/output and supplier risk analysis.

As quality team member worked manufacturing team to completed Machine shop equipment (IQ/OQ/PQ), pFMEA, and process validation, updated existing CNC machine work instructions, Height Gages, CNC Machine coolant preparation, and Optical Comparator.

Provided quality support to Manufacturing Engineering in the creation of travelers, routes, bills of material, print changes, and specifications for in-house manufacturing.

Per management request, participated and conducted Internal Audits of the Quality System, and audits of new suppliers as part of the project team.

Revised and approved test procedures, manuals, engineering drawings and specifications. Worked with CAD in creating BOMs using SAP. Worked with Packaging engineer for the labeling and package design requirements.

Terumo Cardiovascular Systems, Ann Arbor, MI

September 2011 – August 2013


Assigned to dual task responsibilities. Managed and supervised thirteen consultants, developed task-based team approach for equipment validation, process validation, test method validation, gage R&R, supplier qualification, DHF remediation, risk management to comply with timelines.

Completed manufacturing process and documentation gap analysis. Provided quality input to FDA observation response team.

Completed and revised eleven pFMEA risk documents to comply with quality standards. Updated manufacturing process procedures, work instructions, drawing specifications.

Updated calibration schedule and standards for measurement tools such as Height Gages, Bore Gages, and Optical Comparator.

Interacted with manufacturing, quality, and project baseline group.

Managed eleven CAPA projects, initiated, root cause investigation, and closure.

Provided support to complaint investigation team to reduce the complaint back log.

Provided support to supplier audit team, and supplier remediation project.

Beckman Coulter, Miami, FL

March 2011 – September 2012

Chemical reagent/blood count analyzer Manufacturer


Direct report to Senior Quality Director. Responsible for managing, supervising, training two junior quality engineers, and one validation engineers. Provided project updates and reports to upper management.

Assigned to new project team to provide quality/validation engineering support from design phase, product development characterization, specifications development, engineering studies, safety, cleaning, hardware/software/component/supplier specifications/drawings process development, risk assessment, pFMEA for PMA submission.

Reviewed test data trending and updated quality data base.

Updated Master Validation plan, Validation procedures for equipment, process, gage R&R, test methods, validation strategy, planning, site validation plan, template (equipment/operational/functional specifications, IQ/OQ/PQ, and report), risk document, SOPs.

Initiated, executed IQ/OQ/PQ for chemical conjugates and controls manufacturing project which include equipment, process, and packaging (fill/cap/label). Provided process input for filling, capping, and labeling.

Performed gap analysis, provided input on validation activities and updates to manufacturing, quality, regulatory, packaging, engineering, and IT.

Initiated change control, engineering change order, deviation, CAPA, non-conformance, root cause analysis and investigation for complaint handling system.

Initiated pFMEA, validation plan and project plan for cancer drug product for third party

Supplier Audit, internal departmental audit, audit trending, final audit report, CAPA investigations and Complaint handling.

St. Jude Medical, Minneapolis, MN

September 2009 – February 2011


Direct report to Technical Services / validation Manager. Managed and supervised two validation engineers to provide support for completion of project. Participated to project related meeting and provided quality input to project team.

Updated quality inspection plan, master validation plan, site validation plan, as required template updates for equipment/operational/functional specifications, IQ/OQ/PQ, and report, risk document, SOPs.

Assigned to eleven (11) existing opened CAPA projects, completed investigation, root cause, and closure. Initiated change control and engineering change order for revised drawing and work instructions.

Reviewed and approved process and parts related deviation, non-conformance to comply with quality requirements.

Responsible for equipment and process validation projects, where Developed and executed seventeen (17) IQ, twelve (12) OQ, five (5) PQ, two (2) TMV, two (2) Gage R&R. (such as CNC Lathe, Robo Drill, CNC Matsuura, heat sealing process, component turning process, X ray imaging system, fixtures, Heat Bar Sealer, cutters, surgical drill).

Provided additional support per assigned task to complaint handling team to investigate 32 complaints related to production issues.

Updated incoming quality inspection plan, work instructions and procedures. Remediated supplier file to comply with approved supplier list. Revised PFMEA and design (DFMEA) risk documents working manufacturing and product development team.

Provided internal and external quality audit to ensure quality standards. Updated tooling data base and calibration standards to comply with design and process requirements.

Revalidated packaging equipment per revised specification.

Ethicon Endo-Surgery, Inc., (J&J Company), Cincinnati, OH

June 2009 to September 2009


Major responsibility includes complaint handling per quality and regulatory policies and procedures, involved with root cause investigations, resolutions, report and risk analysis to determine critical or noncritical in relation with product impact and functionality, process, equipment, tooling, component, training, design control verification and validation sampling and data analysis, incoming inspection and release. Prepared and managed complaint prioritization and timelines. Interacted with other department, outside vendor to perform full investigation and root cause.

Developed, revised, reviewed and revised quality plan, sampling plan, risk management, change control, NCR, CAPA, procedures, master validation plan, quality plan, DFMEA, PFMEA, regulatory documentations, third party device manufacturer documentations such as GMP, CGMP, QSR, IQ/OQ/PQ/Tooling protocols and reports, reviewed and updated internal and external audits documents, participated and involved with vendor selection team and process, change control, training co-ordination, supplier and audit reports, supplier incoming procedure development, data collection, and statistical analysis.

Established, authored and executed the Process Validation Plan (PVP) for multiple processes and associated equipment that encompassed all deliverables, specifically, the PVP, Product Requirements (PR), Process Performance Requirements (PPR), System Specifications (SS), Equipment Performance Requirements (EPR), Risk Assessment (RA), along with the Installation, Operational and Performance Qualifications (IQ, OQ, PQ), Traceability Matrix (TM), IQ, OQ and PQ Protocols, and the Qualification and Process Validation Summary Reports.

GE Healthcare, Salt Lake City, UT

May 2007 to June 2008


Major contributor in remediation efforts to regain cGMP and FDA regulatory compliance based on signed issuance of a “Consent Decree” of Permanent Injunction.

Performed complaint handling related to finished device of x-ray machine, fluoroscopic imaging work stations, fixtures, functional exerciser, and packaging equipment, processes, and tooling. Based on the complaint investigation, root cause, and final report developed the action plan. Updated and revised work instructions, procedures, training, drawings, change control, CAPA. Completed number of complaint and reports. Submitted all completed and approved complaint regulatory.

Provided the project leadership to remediation activities and timelines. Responsible writing/execution/reports for validation (IQ/OQ/PQ/TQ/TIMV) of a Medical Device system such as OEC 9800, 9900, 6800, 23 1 Camera components, final assembly devices, image fixture towers, IT 3500 systems, engineering studies, associated software systems, Equipment/Process qualifications and verifications Procedures, Master validation Plan, Quality plan, validation remediation plan, sampling plan, and Quality Plan.

Performed process verification, test method validation, gage R&R sampling analysis, procedure revision and updates.

Validated 9900 Workstation Final Assemblies, System Final Assembly, X-ray Camera System, Functional Exerciser Controller, Fixture Tower, Software verifications, and Process Verification.

Responsible for initiating and reviewing quality and validation documentation such as System Design Requirement Specifications (SDRS), Design Requirements Specification (DRS), Drawings, Work Instructions, Discrepancy Report, Non-Conformances, CAPA, Change Control Request, Document Change Notice (DCN), Non-Conformance (NCR), GAP analysis, process verification and qualification, DQ, DHR, protocols, reports, SOPs, test methods, defect investigations, risk management, and training.

Work with operation, engineering and quality for scheduling and execution of validation protocols.

Attended quality and validation staff meeting for project updates.

Provided support to Regulatory for FDA483 response and internal audit/ report.

Provided input to project management, procedures, master validation Plan, equipment and system list, tooling qualifications, equipment parts/ bill of materials, calibration, and EHS review.

Upon completion of initial contractual agreement and with recognition of individual accountability and accomplishment, accepted offer of an additional 12-month extension.

Nephron Pharmaceuticals, Orlando, FL

August 2004 to April 2007

Major manufacturer of sterile pharmaceutical products, where the package product administered through meter dose pump and inhale via the medical device.


Direct report to President (Owner). Managed and supervised two (2) validation associates, ten (10) quality technicians, and three (3) R&D chemists, and chemistry lab supervisor, microbiology lab supervisor. Responsible product released, and managed quality standards and calibration program.

Leadership role to the new and existing sterile product development, quality engineering, equipment qualifications, process validations, packaging, regulatory, and FDA audits.

Responsible complaint handling of sterile finished product line. Provided support in complaint investigation and root cause analysis per quality and regulatory policy. Provided input to regulatory group for the FDA reporting on complaint investigation and corrective action plan.

Developed, executed, reviewed, and approved Technical documents such as SOPs, laboratory test standards and specifications, laboratory instrument validation, equipment validation, process validation, performance validation, method validation, component validation, cleaning validation, data collection, graphs, validation protocols, CSV risk assessment, and final reports.

Revised and performed revalidation for current laboratory and manufacturing processes, methods, raw material, sampling plan, and in-process/finished/release/stability specifications.

Created project management database to track new product process development activities to support the timelines and to implement in timely manner.

Acted as a project leader to implement new and existing product process improvement activities, and coordinated with Q.C, Q.A, Operation, Laboratories, warehouse, and R.A.

Developed, executed, reviewed and approved validation protocol (IQ, OQ, PQ), reports, process improvement study, and validation study. Familiarity with 21 CFR 210, 211, 820, and part 11, ICH, USP, EU, and validation guidelines.

Provided support to regulatory and quality to improve documentation, NCR, and FDA observations/responses.

Project leader on existing product support group, technology transfer, problem solving, process improvement, and equipment selection.

Implemented Empower system for HPLC.

Supervised chemistry manager, microbiology manager, and two R&D chemists, managed calibration program.

Audited raw material, equipment vendors and contract laboratories.

Acted as a team player for vendor qualification, equipment drawing, and process flow chart of FFS system.

Eli Lilly, Manassas, VA

April 2003 to June 2004

Major manufacturer of pharmaceuticals and medical devices, the VA plant is a newly designed sterile diabetic manufacturing product line.


Major contributor, project leader, and team player to drive quality SOPs, cGMPs, GMPs, specifications, and validation to the sterile production equipment and process.

Responsible for (IQ, OQ, and PQ) of Equipment, facility, and combination drug (drug delivery system using medical device). Follow GMP, cGMP, validation guidelines, sops, part 211 and 820.

Team member and validation leader of Component processing team includes parts washers, silicone washers, autoclaves, component processors, raw material dispensing units, (RMDU).

Familiar with cartridge filling line equipment includes filling line, inspection station, plunger station, and disc capping station, bead insertion station, isolator, and washer.

Provided leadership in the development and approval process of user’s requirement documentation.

Responsible for reviewing validation plan, building plan, commissioning plan, qualification plan, protocol templates, Fat and Sat documentation.

Responsible for UR, equipment, system list, system and classification, technical specifications, and data sheet for component processing area.

Provided validation input and technical support in the vendor selection process of autoclaves, washers, and component processing system.

Responsible for evaluating and work with consulting firm for validation activities.

Provided support per assigned complaints in term of investigation, root cause, and action plan.

Pfizer, Kalamazoo, MI

May 2000 – April 2003

Major manufacturer of pharmaceutical products, the MI plant is a designed sterile/non-sterile multiple product lines, and active drug manufacturing.


Developed and executed Installation/Operational Qualifications (IQ/OQ) at Kalamazoo Active Pharmaceutical Ingredient (KAPI) site.

Worked with maintenance/operators/engineer, system owner, and quality assurance during the protocol development and execution.

Reported facility and equipment problems to building maintenance team and aided in troubleshooting.

Responsible CAPA, Quality Control Change Request, Discrepancy report and resolution.

Managed one hundred nine IQ and thirty-five OQ projects on multiple sites.

Performed a dual responsibility as validation specialist and as a project manager. Supervised four engineers, responsible for updating and maintaining a training plan and records, provided update on a weekly basis to upper Pfizer Management.

Prepared a project database and timeline for validation activities.

Provided support per assigned departmental complaints of equipment process, packaging in term of investigation, root cause, and action plan.

Developed batch record and manufactured lab scale, pilot scale, and production size development batches for process study, troubleshooting, and process optimization.

Developed and executed validation protocol for process and equipment qualification (IQ, OQ, PQ)

Generated the data of mixing specificity form the production lots to utilize for future revalidation projects.

Developed and Wrote production ticket variation (PTVA), change control requisition (CCR), investigation and deviation reports for fluid and ointments products. Responsible for deviation, investigation, and final report.

Validated manufacturing processes for liquids and semi solid dosage forms per GMPs, and cGMPs (includes creams, ointments, suspensions, and solutions).

Provided technical support to R&D, production, packaging, validation, engineering, regulatory, and quality assurance.

Acted as a team player for new raw materials evaluation, and Clinical batches.

Provided technical input and support in complaint investigation and report.


B.S. in Chemistry/Biology

Ahmedabad, Gujarat University, India

A.A (Pre-Pharmacy)

Catonsville Community College, Baltimore, MD

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