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Medical Device Company jobs in Dublin, County Dublin

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    • Participate in managing communications with and represent the company in front of HPRA.
    • Thorough working knowledge of GMDPs and regulatory expectations for…
    • Minimum 5 years' experience in medical devices, pharmaceutical, or biotech sectors.
    • This role provides technical microbiology and sterilization expertise,…
    • At least 8 years' experience in a similar role, preferably in a medical devices, pharmaceutical or biologics manufacturing environment, experience supervising…
    • Previous experience in semiconductor manufacturing, electronics, automation, medical device, pharmaceutical or high-tech manufacturing environments would be…
    • Our clients are recognised market leaders in the design, manufacture and supply of high-value engineered products, process systems and technical solutions to…
    • Work safely in accordance with the company's current health and safety policy and procedures.
    • We are currently looking for a Senior Electrical Estimator to come…
    • As part of a busy transport team, our Class C drivers are responsible for the collection, destruction, movement and unloading of confidential waste paper and…
    •  Previous work in pharmaceutical, medical device, food production, cleanroom or.
    • Company positively at all times.
    • Salary: Depending on level of Experience.
    • Work within pharmaceutical, medical device and regulated environments.
    • Experience within pharmaceutical, medical device, healthcare or regulated environments.
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    • Experience within medical devices, calibration or instrumentation is advantageous.
    • The successful Field Service Engineer will be responsible for the…
    • Salary: €46,000 – €52,000 + Company Vehicle | Fuel Card | Lunch Allowance | Benefits.
    • Strong electro-mechanical engineering role.
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    • A well-established specialist engineering company providing installation, maintenance and repair services for lifts across Ireland.
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    • A well-established technical services company providing installation, maintenance and repair services for commercial catering and kitchen equipment across…
    • Salary: €65,000 – €75,000 + Paid Travel Time | Company Van | Fuel Card | Healthcare.
    • Company van and fuel card provided.
    • Good electrical fault-finding ability.
    • Location: Dublin | Full-Time | Permanent.
    • Mix of workshop-based work and field service across customer sites.
    • Diagnose faults and complete breakdown repairs.

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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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