Peter Fleming Email & Phone Number

Cork, IE

Innishannon, Co. Cork, Ireland

• I performed the Commercial disposition of the Vaccine Drug Substance batches. This work was heavily scrutinised in FDA PAI Audits (and more recently HPRA Audits) and there were no findings. I had managed the successful.
• SAP Master Data Build for Commercial Releases
• Reallocation of Clinical Batches in SAP for Commercial Re-Release
• Co-ordination with downstream sites for aggressive market-launch activities
• Vaccine DS Lot Protocol Submission and CBER Approval Process
• Vaccine DS EU OMCL Testing Process.

Innishannon, Co. Cork, Ireland

• First-Project documentation was revised for modified production processes:
• Process Performance Qualification (PPQ) Strategy
• Analytical Test Method Transfer Strategy
• Raw Material Strategy
• Cleaning Validation Strategy
• Equipment Qualification/Utility Qualification Strategy

Innishannon, Co. Cork, Ireland

• Worked in the Aseptic Processing Plant on the disposition of Bulk Drug Product. This involved experience on:
• Grade A and B classified areas
• Aseptic Processing Processes

Innishannon, Cork, Ireland

This project involved the transfer of 15 different manufacturing processes from Merck (West Point) to Ireland MSD (Brinny). I was Quality Lead for the following phases:(1) Capital Phase: Building Construction, Utility Design/Commissioning/Qualification and Equipment Design/Commissioning/Qualification. (2) Analytical Phase: transfer and Qualification of.

Innishannon, Co. Cork, Ireland

• Technology Transfer Co-ordinatorSchering Plough (Brinny) Quality Representative on New Product Introduction Development Commercialisation Team:
• All Prior Approval Inspection (PAI) deliverables up to and including the Technology Transfer Batch were completed.
• Developed a “New Product Introduction Guidelines” share-point database.

Innishannon, Co. Cork, Ireland

• Responsible for the independent review and approval of validation/qualification documentation on behalf of Quality including:
• 21 CRF 11 Compliance (Data Integrity)
• Contingency Fermenter
• Airborne Particle Monitoring System (Grade A/B Areas)
• Restrictive Access Barrier System (RABS) for Grade a Filling Line
• Sterility Test Isolators (Sterility Testing)

Brinny, Innishannon, Co. Cork, Ireland

• Design, Validation and Implementation of:
• Global LIMS System
• Brinny Implementation of Global Electronic Document Management System
• AS/400 INQAS LIMS System and PRISM-LIMS Interface
• Set up of QC Business Planning System

Ringaskiddy, Co. Cork, Ireland

One of the first employees in the start-up operation of the Novartis Ringaskiddy plant. I was responsible both for the implementation and validation of the AS/400 LIMS system.

Pottery Road, Dun Laoghaire, Co. Dublin

Biochemistry and Raw Material testing: valuable laboratory experience in biological assays, wet chemistry and instrumentation.

O'Callaghan's Mills, Co. Clare

Product Development of ELISA diagnostic kits (focused particularly on a Rubella diagnostic kit).

M.Sc., Pharmaceutical Manufacturing Technology (Qualified Person), A

Dissertation Project "Design, Installation and Commissioning of an Airborn Particle Monitoring System for a Sterile Filling Facility"

Apics/Ipics Certificate In Production And Inventory Management (Supply Chain Management), Materials Planning

Modules completed: (1) Supply Chain Management (2) Master Planning (3) Just-In-Time

Irish Management Institute'S Diploma In Business Studies & Management, Accounting And Business/Management

B.Sc., Biotechnology, 2.1 (Honours)

Activities and Societies: Hill Walking Society Final Year Project: "The Production of Lipoprotein Lipase using Chromobacterium Vicosum".

Leaving Certificate, Primary & Secondary Level, Chemistry (A), Mathematics (B), Physics (B), Econonics (B), French & English (C)