Duties:
Support the Material Qualification processes including migration of site-based processes to the global process.
Support management of Quality Agreements.
Support Supplier Change Notification process to ensure appropriate change control and regulatory updates have been made prior to making changes.
Gather data and report quality metrics for internal processes and identify and implement improvement opportunities.
Perform all responsibilities in accordance with company policies, procedures, federal regulations and safety requirements.
Skills:
Minimum of 4+ years’ experience in Quality with GMP pharmaceutical, or biologics experience
Candidates must have GMP material qualification experience/background
Experience in Material Qualification, Procurement, Quality Assurance, or Auditing
Experience with Quality Risk Management and Structured Problem-Solving tools
A strong customer focus and ability to prioritize and adapt to business needs
Knowledge of applicable international GXP regulations and standards
Strong business partner with a focus on delivering results.
Excellent written and verbal communication skills
Strong ability to analyze systems, data
Capable of identifying and mitigating risks
Experience with high performance teams, cross functional projects.
Experience with Technical Writing
Experience working with mature supplier quality system
Previous global Quality System development/deployment experience
Experience supporting regulatory inspections
Education:
B.Sc. or equivalent in Biological Sciences, Chemistry, Microbiology or other science.
Interested candidates should submit an updated CV.
Please click the link below to apply, call William on 0214297900 or alternatively send an up to date CV to William.cunnage@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***
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