Associate Quality Specialist
RK20717
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:

• Required to be proficient in Quality approval and oversight for Commissioning and Qualification activities (IQ/OQ/PQ)
• Provides to the site expertise in Quality Systems and/or Operational Quality, including the following i.e. Quality Notifications/Investigations/ Change Management; environment monitoring programs; sterility assurance/low bioburden manufacturing; etc.
• Uses knowledge to improve Quality Systems and/or Operational Quality; solve complex problems, provide continuous improvement and execute tasks.
• Acts as a resource to colleagues with less experience in Quality Systems and/or Operational Quality
• Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes
• Interprets customer needs, assesses requirements and identifies solutions to non-standard requests.
• Makes decisions within guidelines and policies which impact Product Quality, Projects and Quality Systems.
• Uses knowledge to improve Quality Systems, solve problems, provide continuous improvement, and execute tasks.

• Degree or 3rd level qualification (Science, Quality).
• Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation.
• 5 years’ experience in the pharmaceutical industry or a similar operating environment which includes experience in a Quality function
• Quality Assurance SME knowledge, from both operational and educational experience