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Details

Quality Assurance Specialist


Reference:JSC000122 Location: Limerick
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: EHS Specialist, QA Analyst


We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical 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.

Performs activities in support of dispositioning product while ensuring compliancewith Quality Assurance (QA) policies and procedures, cGMPs, SOPs, and StandardRequirement Documents.


Duties


• Represent Quality Assurance both internal and External with Partners and Contract Manufacturers in support of complex Deviations,Change Controls, CAPAs,etc., including active participation in investigation, evaluation, and problem resolution
• Train and/or mentor junior employees, including providing insights and education on
processes and procedures;
• Provides consultation or advice in alignment with QA policies; and develop an
understanding of external partner and manufacturers site procedures.
• Perform activities associated with reading product records for disposition (e.g.
manufacturing record review, receipt, inspection, document review, shipping, etc).
•Activities may be on site at a partner or contract manufacturer or at a desk
• Review, edit, or approve Regeneron controlled documents
• Review and approval of investigations associated with raw materials, product, laboratory,
facilities, and materials.
• Continually evaluating processes and procedures with an eye toward
continuous improvement



Education & Experience

•Requires BS/BA in scientific discipline or related field and minimum 2 year relevant
experience. Relevant experience may be substituted for education requirements.
• Understanding of aseptic filling and/or packaging operations is preferred.
• Good organizational skills and attention to detail
• Requires good written, verbal and interpersonal communication skills and the ability to
effectively interact cross functionally and cross-organizationally.
• Ability to handle multiple assignments and changing priorities.
• Ability to learn and utilize computerized systems for daily performance of tasks
• Ability to prioritize, manage multiple tasks, and meet deadlines
• Ability to work a varied schedule including off shift and weekends.
• Ability to travel up to 25% of time.