Quality Management System Specialist

Role Purpose:

• A new vacancy has opened up for a Quality Management System Specialist to join our client’s busy pharmaceutical site based in Co. Cork.
• This role requires the delivery of a robust Quality Management System to support a flexible, collaborative, multi-skilled teamwork environment.
• The team working style is one of collaboration, coaching and facilitation to ensure the success of the site.
• The Associate Specialist is accountable for the Quality Systems within the site.

Core Duties and Responsibilities:

• 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 site 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.
• Responsible for the Site Documentation System including Issuance, reconciliation, storage, archiving and retrieval of cGMP documentation to support the manufacture & testing of the products.
• Complete documentation audits.
• Coaches and guides colleagues within the site.
• Responds to non-standard requests from customer needs.
• Makes decisions within guidelines and policies which impact own priorities and allocation of time to meet deadlines.
• Ensures supply of high-quality product through the implementation and oversight of the Quality Documentation System for the site.
• Champion the highest Quality and Compliance standards for the site.

Education & Qualifications Required:

• Sc. Degree or other qualification in Chemical Engineering, Biochemistry, Microbiology, Chemistry or a related field.
• Excellent knowledge in Quality Management Systems
• Experience in a pharmaceutical or a highly regulated environment required.
• Excellent communication and organisational skills.

Please note, we do not require agency assistance with this role.