Quality Management System Specialist
RK21220
Contract – 11 months
Cork
We're currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Cork. 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:Provides to the site knowledge and experience in Quality Systems and/or Operational Quality, including the following i.e. Quality Notifications/ Investigations/ Change Management.Uses knowledge to improve Quality Systems, solve problems, provide continuous improvement and execute tasks.Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes.Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.Supports Corporate Quality to ensure actions related to Quality Systems and/or Operational Quality at the site are executed.Participation in inspections of Site by Divisional / Regulatory Bodies / third parties together with follow up actions where applicable.Ensure supply of high-quality product through the implementation and oversight of the Quality Management System for the site.Ensure the highest Quality, Compliance and Safety standards.The Associate Specialist/ Specialist will participate and comply with the Quality Management System (QMS) requirements, including ownership.The Associate Specialist/ Specialist is accountable for the smooth execution of all appropriate documentation associated within the IPT/QA. He/ She will contribute to the High-Performance culture within the IPT/QA by providing a flexible, accurate service to enable the IPT/QA to achieve four key priorities.Is an active member of the cross functional IPT/QA Team, providing support, guidance and expertise to ensure the success of the IPT/QA.Will participate and comply with the Quality Management System (QMS) requirements, including ownership.Experience and Education:MSc/BSc. qualification (Science)4 years' experience in a pharmaceutical or a highly regulated environment preferably with cGMP experience.Experience with Site Documentation Systems including Issuance, reconciliation, storage, archiving and retrieval of cGMP documentation to support the manufacture & testing of our products.If interested in this posting please feel free to contact Rachel Kent on +353 (0)87 427 8808 or ****** for further information.
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