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Supplier Quality Officer
€45,000 - €50,000
10 Jun 2021
A growing Pharmaceutical Manufacturer is adding a
Supplier Quality Officer
to it's existing Quality Assurance Team. In this role you will be a key contributor to the Vendor Quality Centre of Excellence at the site and have responsibility for oversight on external sites and materials. You will also ensure that the materials at the Tipperary site are meeting GMP requirements.
About the Job:
Serve as a Quality point of contact related to product at External site.
Manage External site to contractual obligations relative to Quality Agreement, specifications, quality, safety and regulatory requirements
Review and/or approve as necessary, completed production batch records, deviations, master batch records, change controls, audits/inspections responses.
Understand and interpret applicable GMP Regulations pertaining to manufacturing and testing activities at External site and use of material on site.
Provide quality oversight of the manufacturing, testing, and release of products at External site. Author and drive actionable site inspection readiness plans.
Identify and mitigate risk at the External site
Monitor and communicate site performances in means of quality metrics through actionable periodic reviews and operating reviews.
Work with Quality team and cross functional team to evaluate supplier performance
Facilitate review of supplier changes
Support in maintenance of Approved Supplier List (ASL)
Escalate risks or roadblocks to management. Drive continuous improvements.
Bachelor/Master degree in Science
3-5 years in a similar role
Ability to oversee multiple projects simultaneously
Experience in managing diverse relationships.
Excellent technical writing skills
Outstanding organisational and time-management skills
Comfortable working in a busy, fast paced regulated manufacturing environment.
For more on the role call Nigel on 087 3618142 or send your CV for consideration.