Accessibility Links

Qaulity Systems Officer

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

We're really sorry, but it looks like this job has already been filled.

Register your CV with us, see our latest jobs or use the search below.

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.