Michael Edey

QUALITY

• Provide Community of Practice Leadership and subject matter support as requested for investigations for Pfizer sterile manufacturing sites for primary packaging and related processes.
• Provide subject matter expert guidance to Pfizer sites and contract matter organisations including review of capital proposals and protocols which includes method selection and application of risk management (assessments).

COMPLIANCE

• Writing of Pfizer corporate quality standards and best practice bulletins.
• Review of compendial changes and regulations relating to primary packaging and container closure integrity.

MANUFACTURING

• Ensure continuity of supply by driving toward zero defects on components through continuous improvement for both Pfizer manufacturing and supplier processes.
• Role requires the compilation and communication of complex technical information to Pfizer colleagues across a wide number of support functions and Pfizer manufacturing sites and its suppliers
• Responsible for utilizing strong technical, industry, and regulatory knowledge to define solutions to challenging issues within Pfizer Sterile Biologics.
• Overseas travel to instrument, capital equipment, consultants, supplier, and Pfizer manufacturing sites to do .....XYZ

ACHIEVEMENTS

• Successful registration of m-RNA COVID 19 products using deep cold storage on two delivery platforms.
• Pioneering use of risk assessments in the field of container closure integrity to prove assurance of processes. Approach was implemented after discussions with global regulators.
• Progressing next generation syringe and vial filling technologies and supporting contamination control strategies.
• PDA Annex 1 Workshop 2023, Presenter and Facilitator
• PDA Quality & Regulations Conference 2022, Presenter
• A3P International Congress 2022, Presenter

QUALITY

• Collaborate with global and local procurement organisation to improve quality, supply reliability and develop new suppliers. Approve or write related risk assessments and protocols for such material changes.
• Approve master processing documentation and protocols as required.
• Act as quality cell lead for Enterprise 1 and related BT projects implementation.

COMPLIANCE

• Present to local and international regulatory agencies and contract customers as required for external audits.
• Undertake major investigations, including leading root cause analysis. Prepare associated documents including FAR's and responses to regulatory agency questions. Approve investigations as a Site Quality Approval Authority.
• Upgrade PGS Melbourne Sterile Injectable site quality systems to conform to international cGMP's and Pfizer PQS as required. Collaborate with centre/corporate and other SI sites to ensure best practice in quality systems as part of continuous improvement.
• Act as quality contact for subjects such as returns of finished products, particulates, inspection methods, container closure systems, sterile consumables, contact items leachables, processing equipment and primary packaging including glass. Perform international supplier audits as lead auditor or as one of three SMEs for glass container manufacturing.

MANUFACTURING

• Visit internationally based supplier sites of raw materials as part of major investigations. Subsequently partner to develop supplier processes and quality systems.

ACHIEVEMENTS

• Warning letter close out with a zero observation 483 inspection in 2015. Individually identified contributing factor for a major citation within the warning letter. Developed a successful strategy to address issue working with support of an international team.
• Received Pfizer Mission Award in 2016 for introduction of new packaging technology to improve product yield.
• Received site award as par of Pfizer Zero defects program for detecting and expeditiously correcting OOS issue thus avoiding production stoppage.
• Selected for inclusion in a GTS sponsored Packaging and Procurement Alliance meeting and associated site visits. As a result become responsible for a non site support role for North American SO sites alternate glass vials qualification.
• Develop strategies for investigations, including supplier investigations and successfully defended these during regulatory inspections.

• Write/update procedures to conform to international GMP's.
• Update systems including Quality systems as part of continuous improvement.
• Perform raw material and finished lot release for product manufactured at the Mulgrave site.
• Undertake major investigations as requested.
• Site preparation for regulatory agency, customer and internal audits and respond to auditors' queries.
• Perform number of site quality audits.

• Responsible for making day to day quality decisions for product noncompliance events for the Mulgrave site
• This involves all aseptic processing including dispensing on all shifts
• Responsible for ensuring that all noncompliance events are correctly documented via central investigations system and that batch disposition and impact on other processes is assessed
• Advise and approve corrective and preventative actions (CAPA)
• Perform investigations into production and customer compliant events that involve detailed technical input.

• Responsible for oversight of production and site services for shift
• This was shared with a second manager except for Friday nights
• All decisions relating to product quality and disposition, with very limited ability to refer decisions to compliance/quality/validation staff members.

Reason For Leaving:

Opportunity to extend myself at Maynepharma / Hospira a Pfizer Company.

Reason For Leaving:

Limited opportunities for advancement.