Grifols Shared Services North America, Inc Quality Assurance Packaging Manager/QP in Dublin, Ireland
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.
Reporting directly to the Technical Director of Grifols Worldwide Operations (GWWO).
The successful candidate will be responsible for a range of GMP and product release support for secondary packaging activities which can include Quality batch documentation review and control, review and approval of controlled documents including batch records and SOPs, quality performance reporting, and support of investigations, complaints and projects.
Applicants will possess a minimum of a Chemistry, Biology, Engineering or equivalent third level degree qualification; MSc in Industrial Pharmaceutical Science and eligible for Qualified Person status, with minimum 10 years’ experience in Pharma Quality Assurance and 2 years QP release.
Strong understanding of pharmaceutical quality processes and systems, manufacturing processes and other support/control systems is desirable.
The successful candidate will be a demonstrated self-starter with a proactive, hands-on approach, possessing excellent interpersonal, decision-making, team work, and communication skills capable to deliver to tight and often multiple deadlines in a dynamic, challenging work environment.
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
Quality Release Activities:
Product release (packaging step)
Establish and manage a Quality Team able to perform the following duties:
Quality Assurance program to maintain cGMP compliance including deviations and CAPA management
In process quality control for packaging operations
Product release of packaged product
Manage all laboratory activities for post packaging ID testing of finished product
Quality approval of ID testing results for finished product
Support product recall 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)
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, customers, etc.
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
Learn more about Grifols
Req ID: 87742
Type: Regular Full-Time
Job Category: Quality