Quality Specialist/Engineer - Sligo
My client requires a Quality Specialist to join their team in Sligo. This is a permanent job, offering amazing career opportunities.
In this job of Quality Specialist, you will be reporting to the Quality Manager. You will provide be responsible for delivery of Quality Assurance activities to ensure product is manufactured in accordance with GMP and Regulatory requirements. The role will also include the review and approval of validation documentation and activities related to the qualification of the facility, equipment, and utilities to support start-up and on-going manufacturing.
What is my client offering you?
- You will have an amazing opportunity to join a successful and expanding team.
- Excellent salary and benefits package
- Excellent opportunities for career progression and advancement.
Key Responsibilities include:
- Site QA point of contact providing technical expertise, feedback and guidance for QA and compliance topics /issues including validation strategy /approach, new product introduction and manufacturing and assist in the resolution of issues commensurate with the level of risk.
- Manage assigned areas of Quality Management System (QMS) to ensure the manufacture of product in accordance with GMP and regulatory requirements.
- QMS areas of responsibility include Deviation, Change Control and CAPA management systems; Internal/External audits; Customer Complaints; Vendor Management; review /approval Manufacturing Batch Records and assessment /approval of production materials.
- Third level qualification in relevant science and/or engineering discipline
- 5 years minimum experience working in a in a GMP Quality environment.
- Experience in a Validation function with strong knowledge of Project Life Cycle and cGMP Regulations
Apply today for this amazing opportunity
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