I'm looking for...

Did you know that your Internet Explorer is out of date?

To get the best possible experience using our website we recommend that you upgrade to a newer version or download another web browser.
A list of the most popular web browsers can be found below. Just click on the icons to get to the download page.

Google Chrome
Internet Explorer
Mozilla Firefox

Your browser will need to close to complete the installation and you will need to manually reload the site when finished
Contact Info
Market Access Manager
Dublin City Centre
QA Manager Biologics
Dublin West
QA Specialist
Dublin West
Qualified Person
Dublin West
CEO Medical Device Start Up
Republic of Ireland
Head of Quality
Dublin West
Snr QA Specialist
Dublin South
QA Manager
Dublin West
Snr Process Engineer
Dublin North
Senior Chemist
Dublin North
QA Manager
R&D Engineer
Program Manager
Principal Scientist
Dublin South
Apply for this job






Salary Expectations:



Current Location:

Notice Period:

Write here your cover note:

If you would like us to create a jobseeker account for you, giving you access to
account management, job alerts and one-click applications, then please tick this box

If you are having difficulty you can always email your cv to applications@lifescience.ie

Quality Engineer Biopharma

Reference:ANFA-230227 Location: Dublin
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: EHS Engineer, QA Engineer, QA Specialist

Quality Engineer Biopharma
Our client, a global biopharmaceutical organisation require a Quality Engineer to join their team on a permanent basis. The Quality Engineer will provide support to the assigned contract manufacturing organizations (CMO) and assigned product lines.

• Process, guide and coordinate quality activities for CMOs and/or product lines, including but not limited to:
o Change management
o Investigations (process, complaint, and laboratory)
o Product release
o Annual Product Review
o Master documents (batch records, methods, labels, etc)
o Validation protocols and reports
o Stability data review / stability coordination
• Conducts CMO audits and supports audits as part of the audit team or lead auditor
• Ensure the stability program adheres to established requirements
• Assist with continuous improvement efforts for projects identified at the CMOs or within the organisation
• Participate actively on cross-functional support and process improvement teams
• Assist in the application of appropriate quality technology tools to establish and maintain process capability and to resolve process deviations and product failures
• Execute quality system procedures associated with the product realization process as well as procedures associated with CMO management and oversight
• Assist with CMO site visits due to identified issues, validation/transfer activity or as routine periodic visits
• Support material review board (MRB) and field alert report (FAR) decisions, including follow up investigation and summary documents
• Support CMOs and the organisation with FDA and other regulatory body investigations and inquiries as needed
• Support scorecard development, maintenance, reporting and action / project development from scorecards

• Minimum BS in Chemistry, Chemical Engineering , related science or equivalent combination of Education, Experience and Competencies
• Certification as Quality Engineer or Six Sigma Black Belt strongly preferred
• Certification as a Quality Auditor or Quality Manager desirable
• Minimum 3 years’ experience in a quality engineer or equivalent role
• Extensive experience in cGMP systems, pharmaceutical manufacturing and testing, experience must include role(s) in a manufacturing setting
• Preferred experience including, but not limited to the following: o Biological product experience
o Application of cGMP to manufacturing and testing
o Product release and investigations
o Change Management and CAPA
o FDA inspections / Regulatory Affairs
o Validation
o Statistical techniques
• Self-motivated and self-managing. Able to identify, execute and prioritize work tasks/projects with an awareness of escalation responsibility as needed.
• Critical problem-solving skills
• Demonstrated data driven decision making ability
• Organizational and operational agility, able to operate at all levels of the organization and able to shift priorities successfully
• Good computer skills, including proficiency with business and technical software (Word, Access, Excel, Powerpoint)
• An understanding of the pharmaceutical industry and its unique business and social responsibilities
• Excellent facilitation and presentation skills
• Ability to plan, organize, and prioritize
• Excellent technical and compliance-based writing skills
• Ability to manage projects involving multiple functional groups without direct reporting authority
• Strong communication skills
• Requires negotiation skills to effectively influence others
• Ability to identify and drive continuous quality improvement

If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252