Grifols Jobs

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Job Information

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.

KEY RESPONSIBILITIES

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

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

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)

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

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