- Cork, Republic of Ireland
- Quality Assurance (QA)
One of Ireland's fastest growing Biotech sites based in Co Cork are now recruiting for a QA Associate to join their growing team. This company specialises in manufacturing best in class therapeutics that provide meaningful advances to patients who live with life-threatening and rare genetic diseases. If you are passionate about your role in Quality and care about the part you play in changing patient's lives, this is the company for you.
As QA Associate, you will be responsible for preparing the site for GMP operations by supporting cross-functional GMP readiness initiatives.
- Review and Approval of electronic and paper production batch records
- Release of Raw Materials for production
- Support the Technology Transfer of a new product into the site including raw material and supplier qualification
- Review and approve new or updates to standard operating procedures (SOPs) and master batch records
- Review and approve Trackwise deviation and investigation reports to ensure that root causes have been identified and appropriate corrective actions have been implemented
- Review and approve Change Control documents
- Support the following activities, as appropriate: Document Control, New or updates to relevant quality agreements, Process and Cleaning Validation activities, Continuous Improvement/Lean initiatives
Education and Qualifications:
- Bachelor of Sciences (BSc) degree, or equivalent, in a technical discipline (physical, engineering, chemical or biological sciences) is required
- Minimum 3 years' relevant experience in a cGMP regulated manufacturing environment (Biotech desirable), with exhibited knowledge and proficiency in Quality Assurance and Compliance
- Experience and ability to work cross functionally
- Experience in supporting manufacturing operations and batch record review is highly desirable
- Ability to comprehend technical information related to equipment, processes, and regulatory expectations
This is a company that cares about the end goal: changing patient's lives.You will work with a team that are like-minded, innovative and passionate about what they do. Given the start-up nature of the business, this is a fast-paced and dynamic environment in which you will work with new technologies and methodologies on a daily basis.
Excellent Salary on offer with this role.
Not sure yet? No CV ready? Give me a call on 01-8883477 for more information
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales