Senior QA Compliance & Audit Leader
Resume:
PAUL H. SMITH
QUALITY ASSURANCE PROFESSIONAL
*********@*****.***
Highland Park, Illinois
www.linkedin.com/in/paul-s-
2897b226
OBJECTIVE
Assertive, objective and goal-oriented Quality Assurance specialist possessing an extensive quality audit, project management and regulatory compliance background in the pharmaceutical and medical device industries.
Seeking a senior level Quality Assurance opportunity where full compliance to global GxPs is expected and required. Consistently maintains an established record of adaptability, integrity, analytical problem-solving abilities and measurable accomplishments. CONTACT
PROFESSIONAL EXPERIENCE
Quality Assurance Manager
Pfanstiehl, Inc.; Waukegan, Illinois 2022 - 2026
• Responsible for ensuring the implementation and continuous improvement of the ICH Q7 based Quality Management System.
• Hosted greater than fifty (50) customer audits annually as well as the US FDA (no 483s).
• Completed all customer technical inquiries and vendor qualification requests (more than 250 annually).
• Performed comprehensive customer complaint investigations leading to closure within the anticipated timelines.
• Coordinated all 3rd party vendor audits. Responsible for overall maintenance of the Approved Vendor List (AVL).
Senior Quality Assurance Manager
Pinnacle Biologics; Bannockburn, Illinois 2021-2022
• Solely responsible for the re-development and implementation of the Pinnacle Quality Management System Standard Operating Procedures and supporting documentation.
• Managed technology transfer of photodynamic fiber optic laser drug delivery systems.
• Final review and approver for all internal and vendor documentation associated with drug product and device manufacturing, testing, distribution and release. Senior Quality Assurance Auditor
Teva Pharmaceuticals; Parsippany, New Jersey and Global 2019-2021
• Project team leader tasked with the design, development and successful global deployment of a risk-based methodology for managing 20K+ active vendors.
• Responsible for the scheduling, preparation, performing, documenting and follow- up of assigned GMP/GDP audits globally on an annual basis EDUCATION
Bachelor of Science in Biology
Elmhurst College, 1999
University of Freising,
Munich, Germany;
Field Studies in Biology,
1999
KEY COMPETENCIES
• Global QA Responsibilities
• Extensive Internal and Vendor
Audit Experience
• Regulatory Audit Hosting and
Remediation Response
• Sterile and Non-Sterile
Manufacturing (Aseptic, TS,
OSD, API, Excipient)
• QMS Continuous Improvement
• Deviation and CAPA
Management
• Development and Delivery of
Live Education Training
• Demonstrated Management
Skills
Extended Resume Available via
LinkedIn profile and Upon Request
PROFESSIONAL EXPERIENCE (CONTINUED)
Quality Assurance Project Manager, Global Operations Fresenius Kabi Deutschland GmbH; Oberursel, Germany and Global 2014 - 2019
• Development of GMP concepts and implementation and Quality Management processes. Further, responsible for harmonization of GxP policies, procedures, systems and processes across seventeen (17) production facilities in the European Union, Africa and Latin America.
• Led a multi-year Regulatory remediation team at a critical production plant in the Fresenius Kabi distribution pipeline (supplied the EU, Africa and the Middle East with hundreds of sterile drug products).
• Prepared sterile injectable pharmaceutical production facilities for inspection readiness by Competent Authorities, including analysis and risk-based assessments against relevant regulatory requirements (21 CFR 211; ICH Q10; ISO 9001; EU Directives and other global requirements).
• Provided continuous professional and organizational support to Fresenius QA Global Operations, Generic Drugs and Standard Solutions (GO GD&SS) and the Production Units
(PUs). Worked onsite and remotely with the PUs to ensure successful implementation of improvement opportunities or necessary Corrective Actions resulting from Regulatory inspections.
• Lead internal and external GxP audits associated with the Global Fresenius Kabi organization from audit planning through execution and Corrective and Preventative Action (CAPA) follow up and closure.
• Developed and executed training events relevant to plant operations, project needs or as identified in the due course of process improvements for all GO GD&SS production units. Senior Quality Assurance Auditor
Fresenius Kabi USA; Melrose Park / Lake Zurich, Illinois and Global 2012 - 2014
• Lead Auditor for external audits of Fresenius Kabi-USA raw material suppliers including APIs, Excipients, contract analytical and microbiological laboratories, contract drug manufacturers and packaging / consumable suppliers.
• Supported the Fresenius Internal audit process as well as announced and unannounced Regulatory audits. Participated in the development of appropriate CAPAs based on observational root cause analysis.
Additional Work History. Detail and Discussion Upon Request Corporate Global Compliance Audit Manager
Hospira, Inc.; Lake Forest, Illinois and Global 2011-2012 Senior Consultant
Deloitte & Touche, LLP; Chicago, Illinois and Global 2010-2011 Corporate Compliance Audit Manager
Coram Specialty Infusion / Apria Healthcare; Mount Prospect, Illinois and Domestic USA 2006 - 2010
Compliance Specialist / Advanced Product Specialist Abbott Laboratories Diagnostics Division; Abbott Park, Illinois 2000 - 2006
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