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Details

QA Specialist


Reference:JSC00020960BR Location: Limerick
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: EHS Specialist, QA Specialist

We’re currently recruiting for an exciting opportunity with an award-winning Medical Device organization based in Limerick. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

Duties

•Determines disposition of raw materials and ensures compliance with Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and Regeneron Standard Requirement Documents.

• Reviews release data, prepares appropriate release documentation and executes release of vendor raw materials.

• Performs AQL visual inspections.

• Manages QA requirements of SCAR process i.e. initiation, review, approval, monitoring

• Support Supplier Quality Group as needed

• Support Warehouse &Logistics Group as needed

• Initiates, edits, review and approves change control and SOPs.

• Provide training as required within the QA Raw Materials Group

• Performs compliance monitoring of area operations and notifies area and Quality Management of any
observed non-compliance.

• Participates in regulatory and customer audits

• Identify gaps in systems and develop feasible plans for correction

• Training of personnel on quality system processes

• Manages direct reports where required i.e. 30:30 performance reviews, manage tasks, coaching/training


Education & Experience


• Requires BS/BA in scientific discipline or related field plus minimum 4 years of relevant experience.

• Minimum 2 years supervisory experience preferable.

•Minimum 2 years Raw Materials industry expexerience perferable.