Technical Validation Specialist

4 days ago


Kilkenny, Kilkenny, Ireland TN Ireland Full time

Our company, TN Ireland, is a leading provider of innovative software solutions in the medical device industry.

Job Overview:

We are seeking an experienced Technical Validation Specialist to join our team and play a crucial role in ensuring the quality and compliance of our software products.

The ideal candidate will have a strong background in software validation and regulatory requirements.

  • Key Responsibilities:
  • The validation and operational management of computerized systems.
  • The creation and review of validation documentation in accordance with regulatory requirements and divisional policies.
  • Responsible for creating Software Compliance assessments such as 21 CFR Part 11 and Data Integrity.
  • Maintaining the quality and compliance status of associated Procedures and work instructions.
  • Presenting and communicating status, reporting metrics, identifying trends, potential issues, and improvement initiatives, as applicable.

Requirements:

  1. A relevant third-level qualification in Engineering, Manufacturing, or Science is preferred.
  2. 2-3 years of working knowledge of software validation in the medical devices industry.
  3. Experience working in a 21CFR820 and/or ISO13485-regulated industry. May consider experience in pharmaceutical validations.

What We Offer:

  • Fantastic new facility.
  • Growing business plus access to many more benefits.


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