Senior Validation Specialist

2 days ago

Waterford, Waterford, Ireland beBeeValidation Full time €55 - €85

Job Overview

We are seeking a Senior Validation Specialist to join our team. In this role, you will be responsible for creating and executing validation documentation and coordinating validation activities.

About the Role

This is an exciting opportunity to work in a dynamic environment where you will be responsible for ensuring compliance with regulatory agency directives and requirements within the medical device and pharma sector.

Key Responsibilities:

  • Create and execute validation plans, protocols, reports, and amendments of the quality management system.
  • Generate applicable quality documentation in conjunction with validation activities.
  • Liaise with cross-functional teams to provide and drive validation inputs and initiatives into operational activities.
  • Liaise with external vendors for validation plans and requirements.
  • Develop validation projects and master validation plans.
  • SUPPORT THE IMPLEMENTATION OF COMPANY POLICIES AND GMP.
  • Support all company safety and quality programs and initiatives.
  • Ensure ongoing compliance with GMP in all practices and recording of events and processes.
  • Perform and generate risk assessment documents for regulated processes within the scope of the QMS.
  • Participate in and drive quality GMP audits.
  • Knowledge and use of LEAN 6 sigma tools for problem solutions.

Requirements:

  • Degree in Engineering/Science discipline.
  • At least 3-5 years' experience in a Validation or Quality Engineering role.
  • Strong working knowledge of process validation and capability.
  • Strong working knowledge of validation and quality principles and practices with key emphasis on EudraLex, ISO13485, ISO14644, GAMP5 and FDA Pharma and medical devices regulations.
  • Ability to work in a cross-functional team environment with excellent initiative, decision-making, and drive for achieving results.
  • Excellent technical report writing, time management, computer, and presentation skills.
  • Excellent interpersonal and communication skills.

About Us

We offer a competitive salary and a dynamic work environment. If you have the necessary skills and qualifications, we would love to hear from you.

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