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R&D quality specialist

Posted on Aug 30, 2019 by Real Staffing Group

Not Specified, Ireland
Health Care
Immediate Start
Annual Salary
Contract/Project

The Quality Specialist will be responsible for ensuring assigned tasks are performed in a timely manner to meet clinical supply requirements, and will be involved in the review and approval of the quality system for global clinical supplies including:

  • Deviations management
  • Change control program
  • Complaints management
  • Preparation and presentation of quality management reviews
  • Review semi-finished batch paperwork
  • Label design/Item master approvals

You will be expected to work with the Quality manager to meet company goals and objectives, customer requirements and regulatory obligations as required by the FDA, EU and regional ministries of health.

Your duties will include:

  • Maintain strong relationships with management and colleagues in the clinical supplies department and articulate the necessary requirements in a clear and concise manner.
  • Work with the Quality Manager to deliver the company quality plan and global regulatory requirements
  • Manage quality requirements for process changes
  • Ensure effective recording, analysis and reporting of KPI's
  • Provide quality input as required
  • Support process changes/validation projects

Requirements:

  • Proven track record in quality in the pharmaceutical/med device industry
  • Third level qualification in a science discipline
  • Clear understanding of working within a regulated environment
  • Communication skills
  • High level of integrity and ethical conduct
  • Ability to prioritise

If you are interested in this position and would like to learn more, please respond to this e-mail, and I will give you a call to discuss. Please note:

Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales

Reference: 750525464

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