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Quality Engineer Chemical Engineering

Location:
San Jose, CA
Posted:
October 16, 2020

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Resume:

David Muchemu

408-***-****

Core Competency and Skill Set

Quality and compliance:

Medical Device QMS design per 21CFR 820.00 and ISO 13485.

Implementation of Pharmaceutical Quality RISK Management per ICH and WHO requirements.

CMO Supplier Quality, Supply Chain, and Capacity Management.

Change control: Performing Risk assessment and Impact assessment.

CAPA: Root-cause Analysis and deviation management

Laboratory controls: ISO17025 Implementation and system Audits.

The complaint, CAPA, and deviation system design, deployment, and Management.

Quality Risk Management, (QRM): ICHQ, EU Annex, and ISO requirements.

Medical Device Design controls: Design Validation, design input and output verification, and design Transfer and DHF compilation.

Quality system Auditing: 21CFR 211/210, 21CFR 820.00, 21CFR 606, and 21CFR 1271, ISO13484 and ISO9001.

Packaging: Validate the packaging line and implement Serialization compliance,

Certified Quality system Auditor: ISO 13485 and ISO 17025

Validation and Equipment Qualification:

Process Validation: Transit validation, cleaning validation, Blending, Compression and Encapsulation

Equipment Qualification: Blenders, Ovens, Mills, Tablet Presses, Film Coaters, Laboratory equipment, Ovens, Autoclaves, stability chambers, Fillers, Lyophilizes, and Encapsulators.

New facility commissioning: Pharmaceutical, medical device, and Tissue.

E-beam and ETO process validation.

Process Failure Mode and Effect Analysis: PFMEA, FAT, and HAZOP.

Equipment Design Mode and Effect Analysis: DFMEA.

Authoring validation and Qualification protocols and reports: IQ, OQ, PQ, and PPQ.

Test method validation: None destructive tests, and destructive tests.

Packaging Line validation: solid dosage and liquid dosage forms. Implementing DSCSA regulatory Serialization traceability requirements

Supplier Quality Management

Develop the Supplier Qualification criteria

Qualify suppliers

Develop supplier Quality matrix

Develop supplier Audit schedule

Audit suppliers

Manage supplier SCARS

Review and approve supplier change requests

Accomplishments

GMP Publications:

Author: Design control For Medical Devices.

Author: How to Design A Pharmaceutical Quality Management system that meets compliance requirements.

Author: How to write Standard Operating procedures and work instructions.

Author: How to design a change control system that meets compliance requirements

Education & Certifications

St Joseph’s University, Philadelphia, Haub School of Business - MBA concentration in Finance and Pharmaceutical Marketing

Warren Wilson College, Asheville, NC - BS Biology and chemistry

North Central University, San Diego, CA - Ph.D.: Business, Concentration: Finance and Statistics

AIU, Miami, FL - MS Chemical Engineering: Concentration in Principles and practices of drug development and USP water purification

Proficiency in the use of MS Office: (Word, Excel, Project, and Visio), Minitab (Statistics), Track wise/SPARTA Digital platform: Quality Management, and AutoCAD (Drawings)

Certifications: Certified USP Water Purification Technician, Certified Quality Engineer, and Chemical Engineer

Experience

LSNE, Bedford NH

Jan 2019- Current

Validation and commissioning consultant:

Perform CIP Cleaning validation

Validate the Lyophilization process

Validate stability chambers

Write the Master Validation plan

Write, review, and approve validation protocols

Perform utility commissioning activities: WIFI water, and compressed gases

Execute validation protocols: IQ, OQ, PQ

Flextronics Inc, Chicago, ILL

July 2018- Jan. 2019

E-Beam sterilization consultant

Perform commissioning activities: FAT, SAT, P&ID, and SIT

Write Qualification protocols: IQ, OQ, and PQ

Qualify equipment

Validate the E-beam process

Westpac Inc., San Jose, CA

Dec 2018 – June 2018 (Contract)

Quality system GMP remediation consultant

Qualify and Deploy Trackwise Quality management subsystems: CAPA, Change control, Equipment

Management and Training subsystems.

Perform laboratory Audits per ISO 17025.

Train personnel on Trackwise workflows in each module

Train personnel on root-cause Analysis methods

Train personnel on impact Assessment methodologies

Train personnel on change control principles

Train personnel on risk assessment principles

Novartis

Dec 2018 - Jan 2019

Quality GMP consultant

Stability, and environmental chamber mapping.

USP purified water system Qualification and validation.

Legacy equipment qualification gap assessment.

Packaging line serialization and validation.

Laboratory equipment validation: Autoclaves, mini-refrigerators, and mixers.

NexGen Pharma, Irvine, CA

May 2016 - Dec 2018

Consultant - FDA GMP remediation

Packaging validation: Validate packaging lines.

Packaging process: develop and implement FDA supply chain serialization traceability specifications

Write reports and validation protocols (IQ, OQ, PQ) for manufacturing equipment.

Perform 21 CFR 210 and 211 gap assessments on the six Pharmaceutical Quality subsystems.

Design the project plan for the implementation of solutions to identified gaps.

Develop DSCSA regulatory and compliance requirements for Serialized and Non-serialized products.

Design and document the Change Control, Deviation, and CAPA systems.

Validate and Qualify packaging line process equipment

Validate the serialization packaging process using the OPTEL VISION serialization system.

Qualify Manufacturing equipment: Blenders, Coaters, Tablet Presses, and Millers.

Perform Oven and Stability chamber mapping.

Develop cleaning sample collection methods.

Investigate process failures: Root-cause Analysis.

Samsung Biologics, Incheon, South Korea

Jan 2015 - May 2016.

Supply chain Quality Risk Management (QRM) Consultant

Initiate CMOs supply chain Quality Risk Management programs.

Develop the supply chain Risk register

Review and amend supplier Quality Agreements.

Develop cross-contamination controls for incoming materials and manufacturing equipment.

Perform Quality System and wet process Audits.

Perform EU and FDA compliance gap assessments.

Lead the Quality organization in EUMA regulatory Audit preparedness.

Develop manufacturing timelines and capacity management.

Train Quality and regulatory personnel.

Manage the supply chain inventory system.

Lead transit and packaging studies.

Map out the supply chain process and identify risks

IMPAX Laboratories, Hayward, CA

Jan 2013 - Jan 2014

Validation Consultant: Quality and Compliance

New GMP Facility commissioning and Qualification.

Qualification protocol development, and Protocol execution.

USP water system validation.

New equipment Qualification: IQ, OQ, and PQ.

Quality and Compliance GAP assessments.

Qualification of the Nitrogen system.

Marquette Cardiovascular, Wayne, NJ

Jan 2013 - Dec 2013

Quality and Regulatory Compliance Consultant (Consent decree)

Remediate FDA identified consent decree validation gaps.

Perform GMP compliance gap assessment per ISO 13485 and QSR on the design control process.

Recommend solutions for identified device software gaps per Part 11 and ISO 62304.

Write Process validation protocols: I Q, OQ, PQ, and PPQ.

Remediate FDA warning letters related to process validation.

Complete gaps in the Process Validation program.

Qualify manufacturing equipment.

Draft Process Validation Master Plans.

Johnson and Johnson (McNeil), FT Washington, PA (Consent Decree)

April 2010 – Jan 2013

GMP Change Control and CAPA Consultant

Perform gap assessment on the change control system.

Manage and lead cross-functional change initiatives.

Design and deploy the supplier change control process.

Develop and implement Impact assessment tools.

Develop and implement risk assessment tools.

Train personnel on change management and GMP principles.

BD Diagnostics, Atlanta, GA

Dec 2012 – Dec 2013

Remediation Consultant (Design Control)

Perform equipment Qualification activities (DQ, IQ, OQ, PQ).

Review and mitigate Design History (DHF)files

Review and revise CMC documentation.

Review and mitigate the DMR.

Lead compliance risk mitigation efforts.

Lead change control activities: Impact and risk assessment.

Reconcile URS and device functional and performance specifications

Review and remediate Design control 483 issues

St Jude Medical, Plano, TX

1/2011 - 9/2012

Remediation consultant (ETO sterilization)

Validation team lead: track tasks and maintain the schedule.

Review and approve protocols.

Perform gap analysis per ISO 11135:2008.

Perform gap analysis per ISO 111727.

Investigate and resolve process failures through the CAPA system.

Write and approve protocols, and final validation reports.

Review and approve process changes.

Perform root-cause analysis

Ethicon: Johnson and Johnson, Cincinnati, OH

Nov 2009 – Dec 2010

Design Control /Technology transfer Quality Engineer (contract)

Lead design control activities.

Perform Supplier Procurement Qualification activities.

Assemble the Design History file

Maintain the Design History file

Maintain supplier change control database.

Review and approve change requests.

Lead Design control Activities: Design input and output verification, Design requirement mapping, design review, and design validation

Investigate resulting CAPAs and deviations control.

Davol Medical, Warwick, RI

12/2008- 9/2009

Sterilization consultant (E-Beam Sterilization/Gamma Sterilization)

Perform Gamma Sterilization gap analysis per ISO1134 requirements.

Perform legacy sterilization Dose audits.

Remediate Product Family Dose mapping.

Write validation protocols.

Determine correct SAL doses

Perform Material Qualification

Review post-market release, surveillance, and correction data.

Develop new Dosimeter placement, and pallet/load configuration maps.

Boston Scientific/Maquet, San Jose, CA

9/2007 – 10/2008

Quality Engineer (Design control)

Lead design input and design output review requirement activities.

Investigate design failures.

Lead DFMEA activities.

Lead URS development activities.

Perform new product Verification and validation activities.

Review Design change requests.

Lead Design control activities (Planning, Design input verification, Validation, Verification, transfer).

Perform material Qualification activities.

Lead new process and new product transfer activities.

Advanced Bionics, Sylmar, CA

11/2006 – 9/2007 (Concurrent Contract)

Senior Process Engineer

Draft Master Validation Plans for the project.

Manage Validation schedules and budgets.

Write validation protocols: IQ, OQ, and PQ

Validate Test Methods, Processes, and the Packaging line

Lead PFMEA activities.

Perform dose mapping studies for Gamma and E-Beam sterilizers

Validate environmental chambers

Investigate process failures: root-cause Analysis

Peak surgical, Palo Alto, CA

7/2009 - 10/2010 (Concurrent Contract)

Quality System Design Consultant

Design the Medical Device Quality system per ISO 13485 and 21CFR 820.

Write Standard operating procedures (SOPs), Work Instructions, Quality Manual, and Quality Policy.

Define and map processes.

Train personnel on GMP principles.

Implement the Supplier Audit, and Supplier Quality Management programs, Electronic Document Management Systems, Process Validation, and Calibration Programs.

Johnson & Johnson (Advanced Sterilization Products), Irvine, CA

12/2009 - 7/2010 (Contract)

Senior Supplier Quality Engineer

Lead Supplier Quality Management activities: Supplier Selection, Supplier Qualification, and certification.

Draft Supplier Quality Agreements

Perform Supplier Quality Audits

Developed supplier performance metrics.

Implement supplier change control, review, and approve Supplier change requests.

Lead Supplier Corrective Action Request (SCAR) activities

Monitor supplier performance.

Baxter, Newark, CA

6/2007 – 11/2009

Quality System/GMP Consultant

Develop a GMP training curriculum.

Managed the CAPA and deviation systems.

Investigate customer complaints.

Lead external supplier Audits initiatives.

Train personnel on RCA methodologies.

Implement statistical process control.

Develop a CAPA matrix for management review meetings.

Performed root-cause analysis.

Lead continuous improvement initiatives



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