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
Develop supplier Quality matrix
Develop supplier Audit schedule
Manage supplier SCARS
Review and approve supplier change requests
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
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
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
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
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