QA Validation Specialist

19 hours ago

Sligo, Sligo, Ireland beBeeQuality Full time €60,000 - €80,000

Job Overview:

We are seeking an experienced QA Validation Specialist to contribute to the development and upkeep of our site validation programme, ensuring all regulatory, quality, and compliance requirements are met.

  • Coordinate, oversee, and participate in the validation and QA of site equipment, utilities, processes, and software in compliance with FDA, European cGMP, and GAMP standards.
  • Develop, maintain, and execute the Site Validation Master Plan, project validation plans and schedules, and prepare validation protocols and final reports to cGMP standards.
  • Conduct validation investigations and implement corrective actions, create, review, and approve quality documents and test data, manage validation, exception event, and change control processes, and maintain and track validation equipment where applicable.
  • Complete all required training before performing any task, document all activities in line with cGMP requirements, update validation procedures, work instructions, and batch documentation to reflect best practices, provide cross-training within the team and support the training of new members, and participate in continuous improvement initiatives for manufacturing, quality, safety, and training systems.
  • Coordinate activities to maximise team effectiveness, ensure overall cGMP compliance within production areas, and communicate with peers and management, escalating events or concerns where necessary.

Required Skills and Qualifications:

To succeed in this role, you will require:

  • Excellent analytical and problem-solving skills
  • Strong attention to detail and organisational skills
  • Ability to work independently and as part of a team
  • Effective communication and interpersonal skills
  • Familiarity with regulatory requirements and industry standards

Benefits:

This role offers a range of benefits, including:

  • A competitive salary and benefits package
  • The opportunity to work on challenging projects and develop your skills
  • A collaborative and supportive working environment
  • Ongoing training and development opportunities

About Us:

We are a dynamic and forward-thinking organisation committed to delivering high-quality products and services. Our team is dedicated to excellence and customer satisfaction, and we strive to create a positive and inclusive work environment.

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