This role is an 11 Month contract with a view to extension.
The Quality Associate Specialist/ Specialist will provide Quality oversight, support, and knowledge to activities relating to Quality Systems across the site and in meeting the Company’s Priorities of Compliance, Supply, Strategy, and Profit Plan. 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/ Specialist is accountable for the Quality Systems within the site.
• Provides to the site knowledge and experience in Quality Systems and/or Operational Quality, including the following i.e. Quality Notifications/ Investigations/LIR coaching; GCM coaching, environmental monitoring program, sterility assurance/low bio-burden manufacturing, customer complaint investigations, etc.
• Uses knowledge to improve Quality Systems, solve problems, provide continuous improvement and execute tasks.
• Provides compliance contribution to project teams and leads small projects.
• May coach and guide colleagues within the site.
• 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 the supply of high-quality products 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.
• Degree or 3rd level qualification (Science, Quality)
• 1 – 5 years of experience in the Pharmaceutical industry or a similar operating environment which includes experience in a Quality function
• Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (i.e. Quality, science, etc.)
• Operational experience of at least 4 QMSs
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