Deirdre Ahern Email & Phone Number

Limerick, Lk, Ie

Ireland

County Limerick, Ireland

• Responsible for generating and maintaining Life cycle documents.• Reviewing and maintaining procedures, policies and other instructional documents • Ensuring consistency by providing guidance and direction in the preparation of all Compliance/Validation documents. • Responsible for generating and tracking Quality compliance metrics.• Coordinate Compliance activities with and seek team support from QA, Validation and Manufacturing.

County Limerick, Ireland

• Responsible for ensuring compliance with all aspects of Quality for Automation/Engineering. • Responsible for generating and maintaining Life cycle document across automation platforms. • Ensuring consistency by providing guidance and direction in the preparation of documents. • Liaising with QA to provide accurate and efficient communication ensuring clarity on technical documentation • Maintaining knowledge of current good manufacturing practices (cGMPs).

Limerick

• Performs technical writing and research to prepare documents including test plans, SOPs, project manuals, protocols, reports, presentations, and other written material.• Reviews validation protocols and reports for conformance to acceptance criteria including regulations, specifications and SOPs.• Initiates and completes change controls and CAPAs in accordance with site procedure. • Utilises planning tools to prepare schedules and assign deadlines for approval of engineering documents.• Completes gap analysis review of documents for compliance with regulatory standards and guidelines.

Limerick

• Achieves competency in chemistry/biochemistry laboratory methods and procedures.• Performs routine and non-routine chemistry/biochemistry testing activities. • Trains other Scientists in laboratory methods and procedures when required. • Executes validation, operation, maintenance, calibration and troubleshooting of equipment.• Writes, executes, reports and reviews IQ/OQ and PQ protocols • Review and approval (where appropriate) of laboratory test results.• Ensures that testing and results approval are completed within agreed turnaround times.• Writes and reviews laboratory TMs, SOPs and WIs.• Deals with non-conformances/ deviations in an accurate and timely manner.

Shannon

Abu Dhabi, United Arab Emirates

Primary School Teacher

Specialist Diploma, Biopharmaceutical Regulatory Affairs

Bachelor'S Degree, Physiology, General