Senior Validation Specialist

7 days ago

Sligo, Sligo, Ireland beBeeValidation Full time €50,000 - €80,000

The role of a Senior Validation Specialist involves overseeing and implementing site validation programs to ensure compliance with external regulatory requirements and industry best practices.

Key Responsibilities
  • Coordinate, direct, and actively participate in validation activities for site equipment, utilities, processes, and software.
  • Ensure compliance with FDA, European cGMP, and GAMP standards.
  • Develop, maintain, and execute the Site Validation Master Plan and Project Validation Plans.
  • Generate validation protocols, reports, and investigations to meet cGMP standards.
  • Implement corrective actions as identified through validation investigations.

Documentation and Compliance

  • Create, review, and approve quality documents and test data.
  • Manage validation, exception events, and change control processes.
  • Maintain validation equipment records and ensure accurate tracking.
  • Document all activities per cGMP requirements and update procedures to reflect current best practices.

Training and Continuous Improvement

  • Complete all required training before performing tasks.
  • Cross-train within the team and support onboarding of new team members.
  • Participate in continuous improvement initiatives across manufacturing, quality, safety, and training systems.

Communication and Team Collaboration

  • Coordinate team activities for maximum efficiency.
  • Maintain overall cGMP compliance in production areas.
  • Communicate effectively with peers and management, escalating issues as needed.

Requirements

Essential Qualifications:

  • Qualification and/or degree in engineering or a scientific discipline.

Experience and Skills:

  • 3+ years of validation or quality experience in medical device plastics processing, moulding, or assembly operations.
  • 3+ years of knowledge in cGMP and regulatory requirements for the medical device industry.
  • Strong communication (written and oral), presentation, and troubleshooting skills.
  • Effective interpersonal and organizational skills.
  • Ability to work independently and collaboratively in a team environment.
  • Strong prioritization and multitasking abilities.

Cognitive Skills:

  • Ability to identify systems and processes requiring validation or QA support, ensuring timely documentation and resolution.
  • Strong communication and motivation skills.

Benefits include professional development opportunities and a chance to be part of a dynamic team working towards excellence in the medical device industry.

Please contact us for further information about this opportunity.

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