As a Quality Engineer - Projects at Vantive Castlebar you will be responsible for managing aspects of quality for a wide range of projects including new product introduction and process improvements.
Vantive Castlebar manufacture critical solutions and medication delivery that extend lives and expand possibilities.
You will work and collaborate with colleagues across many functions including validation, engineering, product development, EHS and manufacturing.
What you will be doing:
* Working within Validation/QA teams on the preparation and execution of protocols for facility, equipment, new product introductions, software and process validation
* Leading and participating on re-validation and process improvement initiatives
* Plan and execute protocol preparation in collaboration with Site Quality, Manufacturing processes
* Project manage the implantation of protocols to demonstrate validation of manufacturing processes
* Responsibility for preparation and sign-off of completed process validation documents
* Prepare and secure validation strategy to regulatory agencies
* Participate in internal / external audits
* Ensure manufacturing operations are maintaining product quality standards
* Certify corrective action is taken to prevent reoccurrence of obstacles
* Authorise stop processes in the event of issues
* Support processing of product complaints and ensuring any corrective actions are taken to prevent reoccurrence
* Review and approve process changes using a Change Management System
* Authorise and approve the dispositioning of non-conforming products
* Participate in the generation, review and approval of risk management, control plans and pFMEA's for new product introduction
We are looking for someone that has:
* 3rd level degree in Engineering, Science or IT
* Minimum of 2 years industrial experience in a QA role preferably in a pharmaceutical, healthcare or similar heavily regulated environment
* Experience in process and equipment validation
* Risk assessment including FMEA techniques
* Good level in understanding of control software and software development and implementation
* Regulatory audit/inspection experience
* Practical experience of both EuGMP and FDA validation requirements
* Experience in representing the validation function at regulatory inspections
* Experience in working closely with site engineering, manufacturing and quality functions
* The ability to work as part of a team to contribute to problem solving and deliver solutions in multi-disciplinary environment
* Able to perform in a demanding high-volume environment and work to deadlines with high-value projects
* Strong analytical and innovate approach to achieve outcomes
* Excellent verbal and written communication skills
What can Vantive offer to you:
* A stable and secure work environment
* A comprehensive benefits package, including private medical insurance, company pension scheme, and annual bonus scheme
* A collaborative and dynamic work environment
* Access to state-of-the-art equipment and technology
* Recognition and reward for outstanding performance
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