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Qaulity Systems Officer

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Waterford
  • Sector: Science
  • Date posted: 14/07/2017
  • Job reference: J368402A

Quality Systems Officer

We are currently recruiting for an exciting new opportunity with a large Pharmaceutical company based in the South East.

Job description

The primary role of a quality systems officer is to ensure that all quality systems are maintained in compliance with company, regulatory and health & safety requirements. Additionally, this is a key role for the site with regards to the design and mapping of our current quality system processes to meet current and future organization requirements.

Responsibilities:

  • Assist with the design and mapping of current quality system processes to meet current and future organization requirements.
  • Responsible for ensuring that all quality systems are in compliance with data integrity requirements.
  • Support administrative resources across the organization to ensure consistency and linking of processes and documents.
  • Oversee the collection, collation and reporting of site quality metrics
  • Provide support in the development of procedures and instructional documentation.
  • Provide operational and project support, where required
  • Administrative support for electronic management systems
  • Investigator and evaluator for any Quality System incident reports.
  • Change Owner and Evaluator for Quality System change controls.
  • Continuously identify and implement system improvements.
  • Generation and presentation of company metrics.
  • Ensure that all work carried out is in compliance with the required standards conforming to company, cGMP, cGLP, SOP's, regulatory regulations and guidelines, safety and environmental guidelines.

Minimum Qualifications & Experience

  • A third level qualification or equivalent work experience in a regulated environment
  • Technical ability to develop procedures and review processes
  • cGMP guideline knowledge
  • Knowledge of QUMAS EDMS and change management system
  • Well-developed, proven experience with Microsoft Office suite
  • Good organizational and interpersonal skills will be required
  • Excellent communication and presentation skills
  • Ability to define and manage own tasks and schedules essential

Skills and Behavioural Competencies

  • Pursues work with energy, drive and need for completion
  • Applies innovative ideas
  • Proven time management skills.
  • Multi-tasking - ability to manage conflicting deadlines whilst maintaining a strong attention to detail.
  • Strong technical writing skills - to present complex data about processes in a clear, accurate and readable format that is appropriate for the intended audience.
  • Quality driven - use of the best business practices and standards in order to meet customer requirements whilst also maintaining compliance to regulatory requirements.
  • Strong problem solving/Analysis - investigate issues to find root causes and to identify areas of improvements.
  • Compliance and adherence to regulations.
  • Communication - write, speak and present information effectively across different communication settings.
  • Adaptability - maintain effectiveness in varying environments and with different tasks.
  • Teamwork and Collaboration - working effectively both within the team and with other departments in order to accomplish company goals.
  • Initiative - taking actions to achieve goals beyond what is required. Being proactive.
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