Senior Quality Assurance Expert

2 days ago

Shannon, Ireland beBeeQuality Full time €65,000 - €75,000

Seeking a seasoned Senior Quality Assurance Expert to provide oversight and support for the Irish Manufacturing site.

Job Description

Provide quality assurance and compliance expertise to ensure seamless operations in a regulated environment.

Key Responsibilities:
  1. Ensure compliance with EU, Irish, and FDA cGxP regulatory requirements
  2. Review and approve quality documentation generated by the Irish operations team
  3. Support a proactive approach to identifying potential issues and minimizing impact through regular facility walk rounds
  4. Generate and prepare quality documents, including SOPs and controlled documents
  5. Monitor investigations, CAPAs, audits, and Quality Review Boards to ensure compliant systems are in place
  6. Prepare and execute regulatory inspections
Required Skills and Qualifications:

A minimum of 10 years of experience working in a GMP-regulated environment is required. Strong knowledge of local QMS implementation, investigations, change controls, and CAPAs is necessary. Proficiency in Microsoft Office and eQMS systems is also required.

What We Offer:

This role offers the opportunity to work in a dynamic and fast-paced environment with a talented team. A competitive salary package and opportunities for professional growth and development are available.

About the Role:

This Senior Quality Assurance Expert will play a key part in maintaining a high level of compliance and QA oversight in the Irish operations team. The successful candidate will have excellent communication and interpersonal skills, with the ability to work effectively in a team environment.

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