Conor Mac Neice

Responsibilities

• Reviewing and executing the QA release of incoming materials and in-process goods via ERP system
• Performing QA review of production documentation associated with quality issues, including deviations, nonconformities and reworks
• Review verification and validation documentation, including but not limited to test plans and reports for equipment qualification, process validation, engineering studies, design verification, engineering change requests, etc.
• Provide QA input into process validation activities
• Conduct the QA review of software tool implementation and validation documentation, such as requirements documents, validation plans, test protocols, test reports, etc.
• Conducting the QA review of equipment documentation, including but not limited to qualification, maintenance, and calibration records

Achievements

• Member of the backroom for HPRA audit of the AAMF Biologics facility
• Scribed for FDA audit of the AAMF Biologics facility
  

Responsibilities

• Providing oversight of quality activities associated with drug substance manufacturing processes
• Supporting ongoing quality assurance responsibilities in support of: Manufacturing oversight and new product introduction including equipment validation, automation changes, SOP and master batch record approval, Change Control, Deviations, CAPAs and Supplier Management
• Performing all responsibilities in accordance with company policies, procedures, and federal regulations
• Be responsible for supporting Alexion drug substance manufacturing and assessing the compliance of this program against best industry practice and current regulatory expectations.

Achievements

• Successfully acquired a Wholesale Distribution Authorisation (WDA) license allowing MSD Ireland (Human Health) to procure and supply Medicinal Product
• Managed the backroom for two successful HPRA audits, one to obtain the WDA license and one to review the Active Substance Registration (ASR)
• Successfully set up the Quality Management System (QMS) which is used for any functions of Merck Sharp & Dohme Ireland (Human Health) that are subject to the WDA license

Responsibilities

• Supporting the QRP in the quality oversight of activities conducted by Merck and Organon in compliance with Merck Policies
• Presenting Quality Metrics for the Merck and Organon Senior Leadership Teams at Quality Review Council meetings (e.g. deviations,inspection outcomes, PQCs, CAPAs)
• Supporting the QRP with local coordination and execution of recalls
• Applying Quality Risk Management (QRM) principles
• Development and maintenance of local Quality training program and job descriptions
• Ensuring effective management of Product Quality Complaints (PQCs) including, tracking, trending, routing the PQCs & samples to the manufacturing site.
• Management and/or review of Product Quality Reviews (PQRs)
• Coordination of Customer Temperature excursion assessment
• Deviation, Change Control and CAPA management, overview and tracking
• Ensuring handling of temperature excursions during transport, warehousing and distribution
• Ensuring handling of complaints related to distribution
• Preparation of Marketing Information Forms and submission to HPRA

• Preparation of Regulatory Certificates of Analysis
• Completed a 5S project on the Quality Assurance Stationery Stores.
• Updating the Quality section of the Swords GMP induction training for new staff
• Updating Regulatory Restrictions Registers, Standard Operating Procedures, Training Requirements, Stability Tables.

• Employee award for demonstrating outstanding collaboration and integrity throughout my time at Jazz Pharmaceuticals
• Successful completion of a Performance Qualification of a Purified Water System, including Purified Water sampling
• Viable and non-viable monitoring of air samples as part of HVAC commissioning test plan
• Testing of laboratory Standard Operating Procedures to confirm their operability
• Reagent and consumable inventory and procurement for Laboratory Services and Operations
• Receipt of samples in Laboratory Services and coordination of shipping samples to a Contract Testing Laboratory
• Gowning for GMP clean rooms