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Quality Assurance Medical Device jobs in Dublin, County Dublin

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    • Thorough working knowledge of GMDPs and regulatory expectations for medicinal products and medical devices.
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    • Good working knowledge of ISO 13485 and medical-device Quality System requirements.
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    • Minimum 3-5 years of experience in a GMP-regulated pharmaceutical, biotechnology, medical device, or radiopharmaceutical environment.
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    • Experience: 2–5 years of relevant experience in a quality department within the medical device industry.
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    • Proven experience in quality management, compliance or quality assurance within an engineering, automation or manufacturing environment.
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QA/QP
R.T.Lane Recruitment
Dublin, County Dublin
•
Hybrid work
Permanent, Full-time
Apply now

Job details

Pay information not provided
Company pension, Private medical insurance, On-site parking
Permanent, Full-time
Hybrid work in Dublin, County Dublin

Full job description

The Quality Assurance, QP has responsibility for the management and maintenance of Quality Management System. Furthermore, the job holder is acting as qualified person as per EU GMP.

Please note: This is a hybrid role with 3 days onsite required in City West, Dublin.

Responsibilities include but are not limited to:

  • Manage the QMS, ensure the QMS is fit for purpose, making changes as necessary approving SOPs and Quality System documents.
  • Maintain Quality processes
  • Participate in managing communications with and represent the company in front of HPRA.
  • Support HPRA inspections and prepare written responses to inspections.
  • Prepare and approve HPRA variations.
  • Provide QA oversight and expertise for New Product Introductions
  • Initiate / approve Non-Conformances (NC), CAPA, change controls and complaints.
  • Ensure annual review of supplier and customer bona fides to verify compliance with Guidelines on Good Distribution Practice.
  • Ensure Batch record review to verify compliance with GMP and Market Authorization prior to batch release.
  • To approve or reject finished products.
  • Ensures that each finished medicinal product batch has been manufactured in accordance with GMP and the MA.
  • Review, and where appropriate, preparation and regular update of technical agreements with licensees and 3rd party contractors.
  • Periodic review of QMS and operational procedures for regulatory compliance through internal audit system.
  • Participating in periodic Quality Operations management review meetings with third parties, annual Quality Management Review meetings, and participating in preparing the agenda and minutes for both meetings.
  • Attending the annual Quality Management Review meeting and participating in the review of the BLIL Quality and Regulatory Compliance Policy and Objectives for continuing suitability.
  • Implementation of the Self Inspection/Internal Quality Audit program.
  • Overall responsibility for reporting and investigation of non-conformances and identification of CAPAs to ensure continuous improvement of the QMS and operational procedures.
  • Escalation of issues as appropriate.
  • The QP must be eligible to act as a European Qualified Person (QP), certifying products in compliance with 2001/83/EC, 2003/94/EC and Annex 16.

Qualifications/ Education:

  • BSc (Hons) in Science or equivalent.
  • QP qualification.
  • Thorough working knowledge of GMDPs and regulatory expectations for medicinal products and medical devices.
  • Minimum of 5 years of experience working in Quality Assurance in the Health Care Industry.

Please reach out to Rachel at RT Lane Recruitment for more details 087 9669394

Benefits:

  • Company pension
  • On-site parking
  • Private medical insurance

Work Location: Hybrid remote in Dublin, County Dublin

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