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Quality Systems Specialist

  • Job reference: 930228
  • Location: Cork
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 26/02/2020

Orion Group Life Sciences have an exciting opportunity for a Quality Systems Specialist for our Multinational Pharmaceutical client based in the Cork area on an initial 12-month contract.


Main Responsibilities of the role

  • 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 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 nonconformance 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

Desired Experience and Background of the successful 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
  • The candidate must have a broad knowledge of cGMPs and prior experience of working in HPRA/FDA regulated facility
  • 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
  • Asserts personal ideas and opinions using persuasion to influence others
  • 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

#pharmaceutical #medical #multinational #product #qualityassurance #qualitysystems #GMP #CAPA

For more information on this role, call Shane O' Neill on +353 (0) 212063407 or email Shane.ONeill@orioneng.com@orioneng.com for a completely confidential chat about this role and other opportunities using the reference number: 930228


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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