Jonathan Fetter Email and Phone Number
Jonathan Fetter work email
- Valid
- Valid
Jonathan Fetter personal email
I am a Pharmaceutical Quality Assurance Professional with extensive global experience in both corporate and manufacturing settings. My process experience includes Annual Product Quality Reviews (APQR), quality incident escalation, quality agreements, stability, recall/withdrawal, investigations, and Corrective and Preventative Actions (CAPA). I have worked internationally and speak Mandarin Chinese at an intermediate level. I am a Certified Quality Auditor (ASQ).My accomplishments include:• As process owner for APQR, supported regulatory inspections, with zero (0) observations for the Annual Product Quality Review (APQR) system.• Led implementation of an electronic document management system (TrackWise) for the APQR system, providing a single source for APQRs globally.• Successfully completed integration of company/product acquisitions into APQR quality system.• Harmonized EU and US APQR systems, ensuring global compliance.• Maintained compliance with APQR completion and annual stability metrics• Member of Global Quality Council (GQC), reporting metrics and risks to management for the APQR, stability, and quality incident systems, and developed system KPIs and metrics.
Almac Group
View- Website:
- almacgroup.com
- Employees:
- 4758
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Almac GroupElverson, Pa, Us
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Qa SpecialistAlmac Group Jul 2017 - PresentCraigavon, County Armagh, GbQA oversight of quality systems and packaging batch record processes.• Perform QA review and approval of deviation and complaint investigations, change controls, CAPAs, vendor queries, SOPs, specifications, and other controlled documentation. • Lead teams performing master batch record generation and executed batch record review and batch release.• Drive timely closure of quality records, and monthly KPI collection/reporting.• Communication with customers concerning quality-impacting events.• Perform internal audits.• Led the back room during 2017 regulatory inspection.
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Sr. Quality Compliance SpecialistShire Jan 2016 - Oct 2016Tokyo, Jp, JpQA oversight of global Supplier Quality and BSE/TSE and Allergen documentation. • Maintain Quality Agreements and Audit documents to ensure supplier qualification and accurate Approved Supplier List. • Author declarations of product TSE and allergen content. Integration of TSE/Allergen and National Drug Code (NDC) systems and external suppliers from company acquisitions.• Provide timely responses to Medical Affairs patient inquiries concerning Shire products.• Member of Shire-Baxalta Supplier Quality Management integration team. -
Apqr ManagerShire 2015 - 2016Tokyo, Jp, JpQA oversight and process ownership of global Annual Product Quality Review (APQR) systems. • Led a four-member team dedicated to performing APQRs for small molecule, biologic, and combination products. • Led cross-functional APQR review meetings; performed review and approval of APQRs. • Authored deviations and CAPA related to the APQR system. • Authored corporate quality standards/quality manual for APQR system.
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Product Quality Governance ManagerShire 2014 - 2015Tokyo, Jp, JpQuality oversight for all company products, as part of the Product Quality Management team. • Led ad-hoc cross-functional quality incident escalation meetings to identify next steps.• Leader of Global Product Council (GPC), a monthly meeting providing visibility cross-functionally to the assessment of process capability and control, driving continuous improvement, and escalating issues to senior leadership.• Conducted annual recall (mock) simulations. • Provided weekly updates to executive management and stakeholders of open incidents. • Continued support of APQR system, providing management review and approval of APQRs.• Performed Pharmacopoeial Surveillance for commercial products.
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Qa Compliance Manager - Apqr And StabilityShire 2010 - 2014Tokyo, Jp, JpQA oversight of Stability and APQR systems. • Led a four-member team responsible for Stability and PQRs. • Reviewed and approved Stability Reports (for NDA Annual Report) and other technical reports. • Led cross-functional APQR review meetings; performed review and approval of APQRs. • Authored deviations, change controls and CAPA related to the stability and APQR systems. • Performed critical evaluation of stability data to ensure compliance with specifications and global regulations. • Standards of Excellence Award, 2012, for APQR system compliance.
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Sr. Qa Compliance AssociateShire 2005 - 2010Tokyo, Jp, JpCollect, review, analyze, trend, and report data for APQRs, and identify and communicate compliance risks to company management.• Collaborated with suppliers and internal employees concerning APQR data and identified issues. • Trended product quality complaints and reported to executive management. • Management of FDA and DEA National Drug Code (NDC) numbers system.
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ContractorJohnson & Johnson 2005 - 2005New Brunswick, Nj, UsTemporary quality position supporting harmonization of material specifications globally into J&J’s electronic document management system. -
Qa AnalystWyeth 2001 - 2004Performed in-process monitoring of production and packaging operations (Floor QA). AQL inspection of finished product. Inspected and released raw materials and critical processing aids in the warehouse. Supported production of influenza vaccine, antivenin, and smallpox vaccine. QA on smallpox packaging line during Federal Smallpox Vaccine Mobilization. Scribe for FDA inspection of smallpox packaging line.
Jonathan Fetter Skills
Jonathan Fetter Education Details
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Temple UniversityQa/Ra -
Kutztown University Of PennsylvaniaCurriculum And Instruction
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University Of Wisconsin-MadisonEntomology
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Penn State UniversityEntomology
Frequently Asked Questions about Jonathan Fetter
What company does Jonathan Fetter work for?
Jonathan Fetter works for Almac Group
What is Jonathan Fetter's role at the current company?
Jonathan Fetter's current role is Pharmaceutical Quality Assurance Professional.
What is Jonathan Fetter's email address?
Jonathan Fetter's email address is jf****@****ire.com
What schools did Jonathan Fetter attend?
Jonathan Fetter attended Temple University, Kutztown University Of Pennsylvania, University Of Wisconsin-Madison, Penn State University.
What skills is Jonathan Fetter known for?
Jonathan Fetter has skills like Quality Assurance, Gmp, Capa, Fda, Pharmaceutical Industry, Change Control, Manufacturing, Technology Transfer, Glp, Validation, Regulatory Affairs, Sop.
Who are Jonathan Fetter's colleagues?
Jonathan Fetter's colleagues are Roger Mortimer, Mark Haugh, Jordan Foy, Shivangi B., Karen Gaebel, Hemant(Niki) Amin, Adele Mcclelland.
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