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Quality Systems Specialist

  • Job reference: 934149
  • Location: Cork
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 19/02/2021

Orion Group Life Sciences have an exciting new opportunity for a Quality Systems Specialist with one of Multinational Pharmaceutical Clients based in Cork on an initial 12-month contract with the view to extension thereafter.

The QS Specialist main responsibilities will be:
* Supporting the digitalization and automating of quality systems to drive data insights, technology, and process innovation
* Reimagine innovation through integrated quality systems
* Drive internal/external partner support to deliver e2e customer value, by supporting the implementation of the next generation Quality Systems.
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 also 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

GENERAL SCOPE OF RESPONSIBILITIES:
Reporting to the QS Team Lead, 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:
o Develops and implements processes, procedures, forms, work instructions and tools related to the implementation of compliance systems at the site.
o Assesses compliance systems on ongoing basis to identify opportunities for process improvement.
o Keeps abreast of regulatory compliance trends

QUALIFICATIONS AND EXPERIENCE:
ESSENTIAL:
* The position of QS Specialist requires a third-level qualification (scientific/ engineering/ IT/ BIS discipline required)
* Experience with one or more data analytics techniques and tools such as Tableau, Spotfire, Google Analytics, Rapid Minor, or Python, and intermediate/advanced Excel will be a distinct advantage.
* 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

DESIRABLE:
* 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 also be a distinct advantage


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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