Tony H.

Experience

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  Astellas Pharma Europe

  Jan 2015 - Sept 2015

  Process Engineering Intern

  Worked in Astellas as a student process engineer in production as part of my co-op placement from university.• Highly regulated cGMP environment. • Worked closely with various other departments on site such as chemistry, micro, EHS and facilities on various projects. • I was involved in several process improvement projects and assisted in the company’s annual product review. • Dealt with any quality issues encountered through management of deviations and the raising and implementation of CAPA’s. • Involved in the validation of operators and manufacturing equipment.• Tracked, logged and reviewed production data on site through the use of SAP, Excel, Microsoft Access, Minitab and limited use of Trackwise. • I also assisted in the implementation of lean practices on site such as visual management and standard work. • I conducted batch record reviews and updated production documentation when necessary. • I helped deal with any customer complaint investigations. Show less

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  Pfizer

  Mar 2017 - Aug 2017

  Process Technician

  Responsible for execution of all tasks associated with the preparation for and production of Pfizer products in cGMP environment ensuring full attention to detail and excellent documentation skills.Assist in maintaining a safe, cGMP compliant work environment at all timesResponsible for completion of tasks according to SOPs and batch records (paper and electronic).Perform initial troubleshooting of issues identified during routine operations.Assist with the investigation of and operations deviations through QTS system, engaging with all relevant personnel and functions as appropriate.Assist where necessary with the training of colleagues in SOPs, process execution and equipment operation.Provide input into the creation and maintenance of area SOPs and batch records.Seek opportunities for Continuous Improvement and embrace Pfizer’s ‘Own It’ culture to own and drive any activities associated with delivering these improvements.Use Lean Tools as part of daily operations (Standard Work, 5S, Method 1, 2 etc) to optimize efficiency and drive the culture of Continuous Improvement and Zero Defects.Where necessary assist in any in Facility and Equipment start up and Validation activities. Provide input on equipment installation, start-up, operation and troubleshooting to support introduction of new products into sustaining operations. Show less

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  Abbott

  Aug 2017 - Jul 2019

  Quality Engineer

  Reviewing customer complaint queries, manufacturing deviations and regulatory requirements against existing historical analysis to identify new issues.Drafting, reviewing, and issuing stop shipments, quality holds and stop build orders and dispositions in alignment with the exception report processes as applicable.Facilitating cross functional meetings to provide recommendations for product control, risk assessments and or field actions.Preparing and participating or facilitating in regular meetings with Senior Level management: Coordinating slides, meeting minutes, and action items.Draft, review and approve process document changes through the Abbott change management system.Identify, write, review and approve exceptions reports and CAPA’s.Ensuring compliance with all Regulatory and Quality policies and procedures including, Environment, Health and Safety.Participate in and coordinate continuous improvement initiatives.Preparation and facilitation of customer and regulatory audits.Performing other duties as assigned by management. Show less

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  Regeneron

  Aug 2019 - Oct 2022

  Quality Compliance Specialist

  • Responsible for ensuring compliance with all aspects of Quality for the Raheen site inclusive of manufacturing, quality systems, quality control, validation, facilities, and materials management.• Administration and oversight of site quality systems including but not limited to;- Deviations- CAPA- Change Control- Audits- Customer Complaints- Quality Risk Management• Responsible for review and approval of the following types of documents, relating to area functions:​- failure investigations​- corrective/preventative action documents• Maintaining electronic systems used for Deviation Management• Provision of monitoring and trending metrics associated with site quality systems · Actively participate in continuous improvement initiatives. • Participates in regulatory and customer audits.• Participates in quality risk assessments.• Collaborates with functional departments to resolve issues and maintain compliance• Identify gaps in systems and develop feasible plans for correction• Training of personnel on quality system processes Show less

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  CSL

  Jan 2023 - Apr 2023

  Quality Assurance Associate - Batch Release

  Responsible for supporting the Quality Assurance operational requirements in QA Batch Release. The role included activities such as:Reviewing batch manufacturing documentation according to schedule to ensure the batch documentation meets quality standards, registered specifications and the approved manufacturing process requirements.Providing administrative support to the QA Leadership at the Parkville site.Providing administrative support, including data entry and review, for business systems, including the electronic Quality Management System (eQMS), Laboratory Information Management System (LIMS), Enterprise Resource Planning (ERP) system, and Document Management Systems. Show less

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  Eli Lilly and Company

  Jan 2024 - now

  Senior Associate - Quality Assurance

  Review and approval of key GMP documents such as GMP standard operating procedures, raw material specifications, sampling protocols, master formulas, process flow documentsReview and approval of GMP documents associated with qualification and validation including IQ/OQ/PQ & validation documents for facility, equipment, computer systems, GMP utilities, analytical methods, and processes, stability data, sampling protocols and Annual Product Reviews.Re-identification, re-evaluation & disposition of raw materials, intermediates and packaging components used in the manufacture of relevant pharmaceutical products where necessary.Evaluation and contribution of regulatory information to regulatory documents Monitoring of GMP compliance, GMP programs including data integrity and systems by ensuring a regular presence the area of responsibilityParticipation in the Site Self-Inspection program and audit of production, systems and service areas for compliance with Product Quality Systems, policies, guidelines and procedures.Report and escalate critical quality issues to the appropriate level of quality management for final resolution. Show less