QA Compliance Specialist 

• Contract Role 
• Swords Dublin

This role will be 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

Key Responsibilities:

This position will include a combination of the responsibilities as follows:

• The main areas of expertise are, but not limited to, specific tasks and roles such as: 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, PowerPoint, 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 MSD Guidelines / Policies and regulatory requirements.

Key Experience:

• 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
• Basic computer literacy
• Strong communication skills
• High level of technical aptitude & motivation
• Demonstrated initiative and pays attention to detail
• Good presentation skills.
• Excellent knowledge of relevant Quality and GMP Compliance Guidelines

Education:

• Bachelor's degree (or higher) in Chemistry, Biology, Microbiology, Automation, Engineering or equivalent

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