Quality Associate Specialist

We are currently recruiting for a Quality Associate Specialist for a Biopharmaceutical Manufacturer based in Co. Tipperary. As the Quality Specialist you will provide Quality oversight, support and knowledge to activities relating to Quality Systems across the site. This role requires the delivery of a robust Quality Management System to support a flexible, collaborative, multi-skilled teamwork environment. The Quality Associate Specialist/ Specialist will have proven capability in development of Quality Systems as an active member, across cross functional teams, to deliver process improvement.

Responsibilities:

• Provide 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.
• Improve Quality Systems, solve problems, provide continuous improvement and execute tasks.
• Provide compliance contribution to project teams and leads small projects.
• Coach and guide colleagues within the site.
• Understand and apply regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes.
• 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.

Job Experience and Qualifications:

• Bachelors degree or 3rd level qualification in Science or Quality.
• 2+ years experience in the Pharmaceutical industry or a similar operating environment which includes experience in a Quality function.
• Advanced PC skills such as Excel, Word, PowerPoint.
• Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation.
• Operational experience of at least 4 Quality Management Systems.
• Knowledge and experience in interpreting current regulatory requirements and providing independent support to the site
• Demonstrated ability to work and succeed within teams as well as leading small project teams
• Stakeholder management of multiple decision makers, auditors, cross functional teams by demonstrating the ability to maintain and strengthen trust relationships with people on all levels
• Proven decision making capability with full accountability and responsibility.
• Lean Six Sigma Yellow Belt or suitable alternative