QA Specialist QMS (Quality Management Systems) required for a leading Biotech facility in Dublin, responsible for supporting the Quality Department.
Ensure that objectives are effectively achieved, consistent with the company requirements to ensure compliance, safety and reliable supply to our customers ROLE: Internal and external inspection and auditing, change control management, quality systems management, GMP training & knowledge management.
Supporting the management of the site Documentation / SOP management systems Provides compliance contribution to project teams and leads specific projects.
Understands and applies regulatory / compliance requirements to their role together with remaining current on upcoming regulatory and compliance changes.
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.
Use standard systems including MS Word, Excel, Power Point, Outlook, SAP and various company and industry specific software such as document tracking, work order entry/tracking, procurement, manufacturing entry/reporting, etc.
Presentation, compilation and review of data as directed Provide quality support to the site, including training and guidance on the interpretation and implementation of Our Company's Guidelines / Policies and regulatory requirements.
REQUIREMENTS Bachelor's degree (or higher) in Chemistry, Biology, Microbiology, Automation, Engineering or equivalent A minimum of 3-4 years experience in Quality Control, Quality Assurance or Pharmaceutical or Biological Operations Knowledge of EU/US quality related pharmaceutical regulations Strong communication skills High level of technical aptitude & motivation Good presentation skills.
Excellent knowledge of relevant Quality and GMP Compliance Guidelines Skills: Quality Assurance Pharmaceutical or Biological Operations