Are you looking for an exciting new opportunity to advance your career in Life Sciences? We are currently looking for a Quality Assurance Specialist to join a Biopharmaceutical Company located in Sligo. This role is a permanent position. Not only does this role offer a competitive salary and benefits package (outlined below), but it will also provide the successful candidate with exposure to state-of-the-art scientific technologies and techniques that will assist their career advancement.
What You'll Receive
- Hybrid Working Options
- Pension
- Healthcare
- Flexi-time
- 22 Days Holidays
- Life Assurance
- Income Protection
Responsibilities | Detailed Job Description Available on Request
As a member of the Quality team, your duties will 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 assisting in the resolution of issues commensurate with the level of risk
- Manage assigned areas of the Quality Management System (QMS) to ensure the manufacture of products 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 of Manufacturing Batch Records and assessment /approval of production materials
- Generate, review, and approve SOPs/other documentation as applicable to your areas of responsibility
- Review and approval of validation protocols/ reports and related documentation to ensure compliance with current EU regulatory expectations and site procedures
- Ensure schedules for review and approval of GMP /validation documents are maintained to support technology transfers and new product introduction project timelines
- Act as the QA lead in QA activities in project work-streams involving cross-functional, multidepartment teams including Operations, Quality Control, Quality Assurance, Engineering, and others
Requirements
As a Quality Assurance Specialist, you will be required to have:
- A minimum of 3 years minimum experience working in a GMP Quality environment
- Experience in a Validation function with strong knowledge of Project Life Cycle and cGMP Regulations
If this Quality Assurance role interests you, please contact Emma Cawley today.