For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.
To complete and support activities within the Quality Department relating to GMP Compliance and raw material/product release. To provide Quality support for the manufacturing operations in Grifols Worldwide Operations Ltd (GWWO).
To act as delegate for all activities within the Incoming Quality Department relating to GMP Compliance and raw material release.
· Communication :
· Daily briefing on Quality batch review/approval
· Provide quality performance information as required
· Ensure regular Quality interaction with other Departments
· Ensure regular Quality interaction with the sister sites on supplier complaints (back up for the Incoming testing Lab)
· Weekly briefing on Supplier complaints ‘ progress (back up for the Incoming testing Lab)
· Quality Release Activities :
· Supervision of quality technician team
· Material release – supervise all laboratory activities for testing of raw materials and ID testing finished product
· Quality approval of ID testing results for finished product
· Oversight of all activities related to the testing of raw materials and ID testing FP laboratory equipment calibration
· Supervision of sampling of raw materials/packaging for quality testing
· Supervise all quality in-process control activities including vial defect inspection
· Quality batch documentation review and control
· Material status assignment
· Responsible for customer complaint investigation
· Support product recall activities
3. Other activities:
· Generation of annual product quality reviews
· Support the process change control system
· Support the quality audit/inspection programmes
· Process/product/system improvement projects
· Drive and oversee process/product/OOS investigations
(including planned / unplanned deviation)
· Provide information to Regulatory Affairs as required
· Training of new Quality personnel
· Review and Approval of Batch records and SOPs
· GMP implementation and site-wide Quality Awareness.
· Facilitate Inspections by third parties, e.g. HPRA, FDA,
· Responsible for follow up corrective actions identified through
the Deviation system.
· Liaise with other Department representatives to promote
improvements in GMP and Quality standards.
· Keep abreast of the latest developments from regulatory
authorities in relation to Quality Compliance activities.
· Participating in the Self inspection program
· Follow up on the suppliers’ investigation reports from the sister
sites and closure of records (back up for the Incoming testing
Knowledge & Skills
· Supervisory experience in a quality or manufacturing setting
· Competence in Microsoft packages specifically word, excel and PowerPoint and in SAP
· Strong Technical Writing ability
· Ability to handle multiple projects and deadlines
· Proficiency in communicating and collaborating at all levels of the organisation
· Demonstrated problem solving skills
· Demonstrated project management skills
· Strong Decision Making skills
· B.Sc. or equivalent in chemistry, biochemistry, pharmaceutical science, or related field. 5 years progressive experience as individual contributor
· M.Sc qualification
· Lead Auditor Certified
Location:EMEA : Ireland : Dublin:Grange Castle (Dublin)
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