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Details

Quality Assurance Systems Manager Remote Working Opportunity


Reference:AUND-218186 Location: Dublin
Qualification:DegreeExperience:5-7 Years
Job Type:PermanentSalary: Not Disclosed

Quality Assurance Systems Manager Remote Working Opportunity
Our Dublin based client, a clinical-stage biotech company are currently recruiting for a Quality Assurance Systems Manger to join their growing organisation. This is a permanent role and offers the option to work for from home. The ideal candidate will have excellent GMP experience from the biologics/biotech industry.

Responsibilities:
• Reviewing, maintaining, developing and continually improving the organisation’s Quality Management System (QMS) and ensuring a Quality culture is present throughout the organisation
• Audit / Review of existing quality management systems, processes, and frameworks
• Implement a quality management system to ensure that the organisations global quality standard is maintained both internally within the organisation and externally with outsourced vendors
• Overseeing compliance with all GCP, GLP and GMP requirements
• Quality Enhancements - Drive quality management framework enhancements (SOP, quality metrics, process improvements etc)
• Monitoring & oversight - Plan and conduct routine and risk-based QA audits and inspections of the quality system to provide assurance of compliance with QMS and relevant standards
• Ensure that audit results / other quality information are formally and consistently recorded and corrective actions/preventive actions are taken
• Perform staff training regarding the quality system, applicable standards and regulations and champion bests in class quality standards across the organisation

Requirements:
• Bachelor’s Degree in Life Sciences
• Proficient in QA procedures and a thorough knowledge of GCP, GLP and GMP requirements
• Specialist knowledge of GMP for biologics/vaccines and sterile injectable dose forms would be an advantage
• 5-10 years quality assurance experience in progressive roles.
• End to end quality systems implementation experience
• Ability to liaise successfully with cross functional stakeholders


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

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