Technical Validation Specialist
4 days ago
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:
- A relevant third-level qualification in Engineering, Manufacturing, or Science is preferred.
- 2-3 years of working knowledge of software validation in the medical devices industry.
- 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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