About Your New Employer:
* Galway based global pharmaceutical company producing wide range of medicines
* Be part of a team that values innovation and continuous improvement.
* Excellent career progression opportunities and a supportive work environment.
About Your New Job as a Qualified Person:
* Perform QA/QP batch release to support operational business requirements, ensuring compliance with EU GMP guidelines and relevant legislation.
* Release medical device finished products to the market as per approved procedures.
* Provide technical expertise for all QA and compliance topics/issues.
* Contribute QA input into Risk Management and support science-based decision making.
* Assist with the development and implementation of performance monitoring indicators for the Quality Assurance department.
* Review documentation/investigations/reports and assist in resolving issues based on risk level.
* Support deviation investigations, including root cause analysis and CAPAs.
* Ensure QA documents and procedures are approved to support technology transfers and new product introductions.
* Actively contribute to continuous improvement activities.
* Work with cross-site teams to implement global quality policies and compliance improvement initiatives.
* Deputise for the Quality Assurance Operations Manager as required.
* Perform any other duties as assigned.
What Skills You Need for a Qualified Person:
* Experience in pharmaceutical/medical device quality systems, including deviation management, CAPA, complaint handling, auditing, change management, supplier qualification, batch release, and management review.
* Ability to handle multiple tasks in a fast-paced environment.
* Experience in Quality Engineering and Lean operational systems in manufacturing is beneficial.
* Working knowledge of risk management tools (e.g., Hazard Analysis and Critical Control Points, Failure Mode Effect Analysis).
* Excellent communication and interpersonal skills.
* Positive attitude with an innovative mindset.
* Self-starter with efficient work methods and excellent initiative.
* Demonstrated people management skills are a distinct advantage.
* Proven success in a team environment, such as project teams or operational excellence teams.
* Excellent communication and presentation skills with a hands-on approach to team leadership.
* Ability to manage requirements of multiple decision makers, corporate colleagues, auditors, and cross-functional teams by building strong relationships at all levels.
What’s on Offer for Qualified Person:
* Competitive salary
* Excellent career progression opportunities
* Work-life balance initiatives
* Bonus scheme
* Health insurance
* Pension
What’s Next
Apply now by clicking the “Apply Now" button or call me, Karolina, on 091749267. If the job isn’t quite right but you are looking for something similar, please get in touch. We also have multiple Temp, FTC, and Contract jobs available.
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