Investigation Specialist

Position Overview

We are currently looking for an Investigation Specialist to join a leading pharmaceutical company in the County Waterford area. The role is an initial 12 month contract with the possibility of extension, focused on quality investigations and ensuring operational excellence and regulatory adherence.

Key Responsibilities

• Lead and coordinate investigations within the events management system, ensuring timely and compliant completion of each investigation.
• Document investigation results accurately in the Phenix Event and CAPA Module, and develop robust CAPA plans to prevent recurrence.
• Support internal and external audits by providing investigative documentation and liaising with subject matter experts (SMEs).
• Provide training support to team members on investigation procedures and regulatory requirements.
• Ensure compliance with cGMP regulations and quality standards at all times.

Required Qualifications

• Degree or higher in a relevant scientific or quality assurance field (e.g., Pharmaceutical Chemistry, Quality Assurance, Quality Management).
• Extensive knowledge of cGMP within a regulated environment and understanding of quality systems.
• Proven experience leading investigations and developing CAPA plans in highly regulated sectors.
• Strong planning, organisational, and technical writing skills.
• Excellent interpersonal and communication skills, with the ability to work independently and adapt to varying priorities.

This is an equal opportunity employer.