Overview
Project Quality Engineer Jobs in Castlebar, County Mayo, Ireland at Vantive
Title: Project Quality Engineer
Company: Vantive
Location: Castlebar, County Mayo, Ireland
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 extends lives and expands 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
