Derek Moore Email & Phone Number

Dublin, County Dublin, Ireland

Ireland

Ensure compliance with cGMP, corporate standards/Pfizer Quality System (PQS), Site policies/procedures, regulatory requirements and industry standards.Partner closely with customers and stakeholders to understand and deliver on all compliance requirements within timelines and escalate where necessary through the IMEx Material Supply Ecosystem infrastructure.Participate in cross functional teams as required to provide consultative support on quality related issues. Provide support with investigations and resolution of discrepancies e.g. Investigation Method 1's etc. Assuring completeness in terms of root cause, action taken and CAPA effectiveness.Authors, tracks and review for adequacy, Procedures, investigations, commitments, change controls, forms, logbooks, protocols and reports etc.Manage rollout of DI process in Supply Chain to assure compliance with corporate requirements.Responsible for the running, managements and co-ordination of the following important forums on behalf of the Supply Chain team;Weekly Change Review Panel (CRP)Local Site Inspection Readiness Committee (SISC) and Cross site SISC.Weekly Supply Chain QTS System meetingQuarterly Deviation Trending process as part of the SQRT.Support & guide Supply Chain project teams from a compliance perspective to ensure robust project execution and delivery of value.Ensure inspection readiness program is functioning effectively.Carry out cGMP compliance process and area walks.Support and participate in Internal Quality audits as per the site inspection calendar.Preparation, Support and participate in all Board of Health and Regulatory InspectionsReview and approve internal audit reports and co-ordinate Regulatory and Board of Health Audit responses as required.Create Supply Chain compliance community of practice and/or common interest groups to leverage and share across our Biotech networkParticipate in forums required to support the operation of Quality systems/processes.

Carlow, Leinster, Ireland

• Implement SCN's (Supplier Change notifications) in a timely manner in accordance with site and global procedures, prior to affected materials being delivered to/used on site including the management of site supplier change controls.• Manage the co-ordination of the change notification process, tracking and cross-functional collaboration.• Engage with the global 'Change Management System' team to ensure alignment on global changes, Key performance indicators are met and provide feedback on supplier changes impacting the site.• Support and manage deviations - liaise with External Manufacturing, sites (sending or receiving) on investigations related to materials, drug substances and drug product shipments using standard tools and methods - Fishbone Diagrams, 5 Why’s. Identify and implement corrective and preventative actions.• Format, write, deliver, and review necessary SOPs, Work Instructions, training documents and change controls in line with the standard approval process.• Create and maintain Material files including Material Specification documentation.• Assist in the management of Supply Chain Management training.• Manage area metrics and KPIs

Newbridge

• Cultivate process improvement initiatives including Management of Controlled Drugs process and Product Obsolescence process.• Develop/deploy new processes and technologies - Shipment of Dangerous Goods practice and implementation of a new Warehouse Management Logistics application (IPL).• Conduct Periodic reviews of SOPs ensuring procedures are compliant with industry and network Quality standards.• Support and manage investigations and deviations ensuring problem resolution and appropriate and robust corrective and preventative actions are put in place.• Facilitate, execute and supporting FMEAs for system analysis and identification of potential failure modes, causes and their effects on product quality. Execute HAZOP studies for identifying potential hazards on production lines.• Administer shipments of “Dangerous Goods” products as a Dangerous Goods Safety Advisor (DGSA).• Draft and mange site change controls including impact assessments, change tasks and material control.• SME for Controlled Drugs - Liaise with the Health Products Regulatory Authority and manage controlled substances in line with HPRA Guidance on Import and Export Licences and Letters of No Objection for Controlled Drugs

Newbridge

• Support Process Validation, Equipment Qualification and Cleaning Validation activities within the Packaging and Processing areas.• Draft, execute and approve qualification protocols for site Packaging, Processing equipment and HVAC equipment involved in direct production & production support in line with project schedules.• Execute the qualification program within the Packaging area in Line with the VMP and Business requirements.• Review and approve GMP documentation including: Packaging Process Risk Assessments, project documentation, User Requirement Specifications, Functional Design Specifications, Factory Acceptance Tests and Site Acceptance Tests.• Area SME for internal/external audits and inspection (including HPRA & FDA) and commercial partners.

Dublin, Ireland

• Provide internal auditing of ISO systems and certifications• Prepare for ISO recertification and surveillance audits and assist with implementation. • Develop and maintain quality control systems and checks• Monitor and act on quality control statistics• Lead, participate and support continuous improvement initiatives• Monitor and review feedback register and ensure corrective actions

Higher Diploma, Human Resources Management And Services, Honours

This intensive programme provides change leaders with the skills, tools and techniques necessary to implement effective change.

Masters (Formerly Mie), Engineering Management

The Master of Engineering Management programme is designed for engineers and other technology professionals who are developing careers.

B.Eng (Hons), Manufacturing & Design, 2:1

Manufacturing and Design Engineers are involved in the design of products and could manage the machines, resources and economical use.

Diploma, Quality Management

Education record