Quality Specialist - Quality Management System

Ref. 1354

Quality Specialist - Quality Management System

An amazing opportunity has arisen with our client, a leading global pharmaceutical company, for a QA Specialist in Quality Management Systems (QMS) at their site in Swords.

The successful candidate will be responsible for supporting the Quality Department, ensuring that objectives are effectively achieved, consistent with the company requirements to ensure compliance, safety and reliable supply to our customers

Responsibilities include but are not limited to:

• Support internal and external inspection and auditing, change control management, quality systems management, GMP training & knowledge management.
• Support the management of the site Documentation / SOP management systems
• Provides compliance contribution to project teams and leads specific projects.
• Utilise 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.
• Apply 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.
• Prepare, compile 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:

• A Bachelor's degree (or higher) in Chemistry, Biology, Microbiology, Automation, Engineering or equivalent.
• 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 skillsHigh level of technical aptitude & motivation
• Demonstrated initiative and attention to detail skills
• Excellent knowledge of relevant Quality and GMP Compliance Guidelines
• Good presentation skills.