Quality Systems Specialist

The role:

PE Global is currently recruiting for a Quality systems Specialist on behalf of a leading pharmaceutical company based in Cork. This is an initial 11-month contract role.

Description:

• 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.

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 MMD 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 MMD 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 MMD Quality Management System (QMS) requirements, including ownership.
• Primary activities/responsibilities:
• Provides to the site knowledge and experience in Quality Documentation Systems. ·
• Responsible for the Site Documentation System including Issuance, reconciliation, storage, archiving and retrieval of cGMP documentation to support the manufacture & testing of our 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 and Experience:

• Bachelor’s degree, or higher (Science/Quality/Technical). 
• Experience in the pharmaceutical industry
• Excellent communication and organisational skills

Interested candidates should submit an updated CV.

Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***