Experience

Nelipak Healthcare Packaging

• United States
• Packaging & Containers
• 300 - 400 Employee

• Senior Quality Compliance Engineer

  • May 2023 - Present



Grifols

• Spain
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Systems & Compliance Manager

  • Jan 2023 - Apr 2023



Bionical Emas

• United Kingdom
• Pharmaceutical Manufacturing
• 200 - 300 Employee

• Quality Assurance Manager

  • Aug 2021 - Jan 2023



PPD

• United States
• Research Services
• 700 & Above Employee

• Senior Compliance Specialist

  • Mar 2019 - Aug 2021



Integra LifeSciences

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Supplier Quality Engineer

  • Feb 2018 - Feb 2019



Pfizer

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Specialist

  • Oct 2014 - Feb 2018

  Supervision & maintenance of quality system's. Provide quality oversight & ensuring compliance with regulatory requirements ( GMP & Controlled Substances). Ensure strict adherence to site policies / procedures, cGMP & environmental, health & safety regulations. Execute responsibilities in line with Right First Time principles. Ensure resolution of and/or appropriate escalation of issues. Identify continuous improvement opportunities and progress continuous improvement projects. Support the introduction of new products. Manage and maintain the Documentation System. Advisor on documentation & archiving issue's to site personnel. Conduct periodic reviews of all Quality Agreements. Compilation & approval of report investigations. Provide QA guidance to the Manufacturinf / Packaging / Laboratory and assist with the identification & investigations of QAR's (quality assurance reports) & LIR's (laboratory investigation reports). Show less



SteriPack Contract Manufacturing

• United States
• Medical Equipment Manufacturing
• 100 - 200 Employee

• Quality Engineer

  • Apr 2002 - Oct 2014

  - Investigation of production issues, containment & analysis. - Customer complaint evaluation, analysis, reporting and timely closure. - Complaint trending and monitoring of corrective actions. - Control on Non-Conforming Material Review. - Development, issuance and implementation of QA documentation. - Liaise with superior and other functional supervisors routinely. - Participate in the development, validation and implementation of the manufacturing processes and equipment for existing and new products. - Manage / execute site quality systems including CAPA, internal and supplier auditing, product release and validation activities. - Lead Problem Solving, Failure & Root Cause Analysis, Risk Assessment & FMEA activities within the Team. - Adherence to regulatory standards including ISO 9001, ISO 13485, FDA 21 CFR Part 820. - Delivering in-house training on quality assurance concepts and tools. Show less



Flextronics

• Tuallmore

• Quality Technician

  • Dec 1998 - Apr 2002

  - Carry out Internal and External audits - Execute internal audits. Raise non conformances and ensure all observations raised were closed out - Trouble Shooting of metal press machines - Routine Patrol Inspection. - Document Control, updating documents through change request. - Carry out Internal and External audits - Execute internal audits. Raise non conformances and ensure all observations raised were closed out - Trouble Shooting of metal press machines - Routine Patrol Inspection. - Document Control, updating documents through change request.