QA Regulatory Affairs Specialist

2 days ago

Cork, Cork, Ireland beBeeValidation Full time €80,483 - €113,312

Job Overview:

We are seeking a highly motivated QA Validation Manager to lead our validation processes, ensuring adherence to all relevant regulations and standards. The role will also address site safety requirements alongside applicable GxP and Good Manufacturing Practices (GMP).

Key Responsibilities:

  • Develop and manage comprehensive validation processes and procedures.
  • Oversee compliance with software and hardware validation regulatory requirements.
  • Offer validation support and expertise for various projects.
  • Assist in regulatory submissions, failure investigations, CAPA initiatives, and ongoing improvement efforts.
  • Build and maintain collaborative relationships across the organization and with external customers.
  • Prepare validation reports, data, and Key Performance Indicators for senior management presentations.
  • Cultivate leadership and operational skills of direct reports.

Requirements:

  • Bachelor's Degree in a quality or science-related field.
  • At least five years of experience in drug manufacturing, medical devices, biologics, or a related industry.
  • Demonstrated experience in supervising and motivating teams.
  • In-depth knowledge of GMP, FDA regulations, SOP development, and a strong grasp of Validation and Data Integrity Principles.
  • Excellent analytical and problem-solving abilities.

About Us:

Our company is committed to creating access and opportunities for growth at your own pace. We believe this variety drives excellence and innovation, strengthening our ability to lead in science and technology.

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