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Details

Quality Engineer Biopharma


Reference:ANFA-230227 Location: Dublin
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: 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.

Responsibilities
• 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
o CAPA
• 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

Requirements
• 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