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.

Shannon

Abu Dhabi, United Arab Emirates

Primary School Teacher

Specialist Diploma, Biopharmaceutical Regulatory Affairs

Bachelor'S Degree, Physiology, General