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Job Ref.: 1771

Job Title: Quality Specialist – Medical Devices – Dublin West – 1 Year Contract – July 2019 - Urgent

Posted Date: 19/07/2019

Sector: Quality

Location: Ireland, Dublin West

Job Type: Temporary / Contract

Job description:

Quality Specialist – Medical Devices – Dublin West – 1 Year Contract – July 2019 - Urgent

Our client a major Medical Devices company, based off the Long Mile Road, Dublin wish to appoint a Quality Executive to join their Quality team.

They require an experienced, motivated, innovative and enthusiastic individual to join our Quality Team.

The position of Quality Specialist requires the efficient and consistent management of the Quality Management System in compliance with current GDP regulations for medicinal products & medical devices and I. S. EN ISO 13485: 2016 and is currently for a one-year contract

The position reports directly into the Quality Manager.


Support the Quality Manager in maintaining compliance with Good Distribution Practice (GDP) for Medicinal Products and Medical Devices and the I. S. EN ISO 13485:2016 standard. Assist the Quality Manager in the development of a number of continuous improvement and compliance projects within the Quality Department.

Document Management System:

  • Defining and periodically updating Quality Procedures in conjunction with operating staff, while ensuring compliance with I.S. EN ISO 13485: 2106 and GDP.
  • Restructuring the Document Management System in compliance with the Corporate Integrated Management System.

Audits

  • Conducting quality audits against the I.S. EN ISO 13485:2106 standard and Good Distribution Practice. Preparing audit reports, assessing and verifying planned corrective and preventive actions and reviewing the effectiveness of the corrective and preventive actions taken.

Training:

  • Ensuring the Quality Management system (QMS) is understood by providing training to B. Braun personnel regarding updated documents.
  • Maintaining Quality Training Files.

Incidents /Deviations

  • Recording, investigating and reporting incidents and deviations to the Responsible Person.

Quality Risk Management

  • Assisting Risk Owners and Process Owners in assessing risks and assigning counteractive measures.

  • Maintaining Quality Risk Management files.

Outsourced Processes

  • Conducting Supplier Audits and Assessments, as required.

  • Managing Contracts and Technical Agreements

Change Control

  • Documenting and managing change controls through to completion.

Skills & Experience Requirements:

  • A solid understanding and working knowledge of GDP and the I.S. EN ISO 13485:2016 standard.

  • A relevant 3rd Level Qualification along with previous experience of >2 years in a Quality Assurance Role in the Medical Device /Pharmaceutical Industry.

  • A qualified and experienced Quality Auditor capable of leading compliance audits.

  • A knowledge of Quality Management Systems.

  • A hands-on individual with exceptional verbal and written communication skills who possesses a proactive and collaborative work style and the ability to work with multiple priorities and deadlines.

  • Accuracy and excellent attention to detail are key attributes along with excellent organisational skills.

  • Proven interpersonal skills and the ability to communicate with people at all levels within an organisation.
  • Must be highly proficient in Microsoft Office Applications and Document Management Systems.

An excellent salary (circa 38-40K) plus benefits will be offered to the successful candidate.

For further information, please call Paul Flanagan at Dublin 01 805 5522 or email your c/v in the strictest confidence to paul@pharmasolutions.ie asap

 

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