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Vacancy Details


Quality Systems Specialist (days) - Cork - 103121

Contract Type: Contract
Location: Cork
Date: 19/03/2019
Job Reference: 103121
Contact Name: Orla Crowley - Healy
Contact Email:

Job Description

Quality Systems Specialist (days) - Cork - 103121
Quality Systems Specialist (days)

Our client is a pharmaceutical company based in Cork looking for A Quality Systems specialist

Department: Quality Systems
Report to: QS Manager

Job Summary
  • The candidate must have a broad knowledge of cGMPs and prior experience of working in HPRA/FDA regulated facility. The candidate must also build customer value through effective collaboration and influencing others, as well as consistently delivering on goals and objectives under minimal supervision.
  • The individual will be responsible for (some of the following):
  • Internal Audit Program
  • Management of the document management system- which can include supporting and advising Documentation Control administration personnel, as required
  • GMP service providers program
  • Managing the non-conformance system and CAPA process
  • Quality agreement process
  • Change control process and system
  • Supporting site regulatory inspections where appropriate
  • Supporting the site induction process
  • Metrics and report generation from the quality systems

  • Reporting to the QS Manager, the person will be responsible for the following:
  • Providing support, direction and training to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met.
  • Partners with other departments to ensure that compliance systems are implemented in an efficient manner.
  • Supports the development and management of GMP compliance systems through the following activities:
  • Develops and implements processes, procedures, forms, work instructions and tools related to the implementation of compliance systems at the site.
  • Assesses compliance systems on ongoing basis to identify opportunities for process improvement.
  • Keeps abreast of regulatory compliance trends.

The Ideal Candidate:
  • The position of QS Specialist requires a third-level qualification (scientific/ engineering/ IT/ BIS discipline required)
  • A minimum of 3-5 years’ experience within the biological and/or pharmaceutical/ medical device industry
  • Knowledgeable of FDA/EMEA regulatory requirements
  • Demonstrated knowledge and application of industry regulations as they apply to systems including those of FDA, HPRA, EMEA and other authorities
  • Experience of managing project groups or leading teams
  • Skilled in the use of problem solving tools/techniques
    Experience with systems such as Trackwise and electronic documentation management systems will be a distinct advantage
  • Customer focus is critical
  • Builds strong productive relationships
  • Demonstrates ability to work with teams and individuals
  • Asserts personal ideas and opinions using persuasion to influence others
  • Seeks opportunities to grow and develop professionally
  • Uses best practices to improve business operations
  • Holds oneself accountable for compliant and flawless execution
  • Effectively manages and adapts to change
  • Demonstrates the courage to stand alone on ideas and opinions that differ from others
  • Listens effectively and remains open to other’s ideas.
  • Works effectively with people that have diverse styles, talents and ideas
  • Maintains the highest standards of ethical behaviour
  • Attention to detail and strong administrative skills

For further information on this Quality Systems Specialist in Cork please contact Orla on 086 0449473 /

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