About Us
We are a leading healthcare organization that helps people live more fully at all stages of life.
Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines.
We serve people in more than 160 countries worldwide.
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Job Description
The Quality Validation Engineer is responsible for implementing and maintaining the effectiveness of our Quality System.
* Responsible for reviewing and approving validation deliverables for Equipment, Facilities, Utilities, Software, Spreadsheets and Analytical validations.
* Develops and maintains Quality System procedures.
* Ensures safe and effective products meet customer needs while maintaining compliance.
* Monitors and maintains quality and compliance status of associated quality records.
* Maintains quality and compliance status of associated Procedures, work instructions and training materials.
* Presents and communicates status, reports metrics, identifies trends potential issues, improvement initiatives as applicable.
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Responsibilities
The primary responsibilities of this role include:
1. Implementing and maintaining the effectiveness of our Quality System.
2. Reviewing and approving validation deliverables.
3. Developing and maintaining Quality System procedures.
4. Ensuring compliance with regulations and industry standards.
5. Monitoring and maintaining quality and compliance status of associated records.
6. Presenting and communicating status and reporting metrics.
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Requirements
To be successful in this role, you will need to have:
* A relevant third-level qualification in Engineering, Manufacturing or Science.
* Minimum 2 years of experience in Engineering, Manufacturing or Scientific roles.
* At least 1-2 years of validation experience within manufacturing or testing laboratories with emphasis on software and equipment validations.
* Strong analytical and problem-solving skills.
* Strong communication (written and oral), presentation skills required.
* Experience of Manufacturing Execution Systems is desirable.
* Experience of manufacturing Database is desirable.