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Quality Engineer II

  • Location:

    Tipperary

  • Contact email:

    jsimilak@sigmar.ie

  • Sector:

    Engineering

  • Contact phone:

    +353214315770

  • Job type:

    Full Time

  • Job ref:

    JSiQEIIBS3105

  • Salary:

    Negotiable

  • Published:

    17 days ago

  • Contact email:

    jsimilak@sigmar.ie

Job description

Currently seeking an experienced Quality Engineer who is ready to take on a challenge in a globally leading medical devices company.

Job Responsibilities:

  • Reviewing and writing reports, procedures and validation documents in support of establishing pharmaceutical quality system to GMP requirements. 
  • Subject Matter Expert regarding Acceptable Quality Standards and GMP practices for products and processes.
  • Providing effective and responsive QA support to Operations to meet their area’s objectives of quality, cost and output.
  • Evaluating quality events ensuring compliance with cGMP and quality standard requirements.
  • Supporting root cause analysis, product impact assessments and corrective and preventative actions (CAPAs) for quality events.
  • Ensuring all process variables and their interactions are adequately defined. Ensure all failure modes in process have been identified and addressed.
  • Ensuring Regulatory compliance in area of responsibility for GMP pharmaceutical regulatory agencies (FDA, HPRA etc.)
  • Providing functional expertise to other support functions on quality related issues.
  • Identification and implementation of appropriate statistical techniques to monitor process performance.
  • Approval of change requests for product, process and quality system changes.
  • Validation: Define process and product validation requirements, preparation and approval of Master Validation Plans, protocols and reports approval.
  • MRB: Review of MRB trends and identification of appropriate corrective actions when required.
  • Supporting the implementation of Lean Manufacturing across the site.

Job Requirements:

  • 2-5 years’ experience in Manufacturing or Quality with a Level 8 qualification in Engineering or related technical/Quality discipline.
  • Previous experience in a Quality, or Manufacturing background, particularly in relation to pharmaceutical quality systems
  • Experience in the pharmaceutical industry and GMP manufacturing
  • Working knowledge and understanding of FDA, HPRA, and the pharmaceutical industry quality requirements and associated with manufacturing controls.
  • Experience in problem solving and process improvement methodologies
  • Process Validation, Risk Management, CAPA experience.
  • Demonstrated ability to work with cross functional organizations in a dynamic manufacturing environment to solve problems
  • Strong command of MS Office – Word, Excel, PowerPoint.

For a confidential discussion on this or any other job opportunities please contact Jakub on 021 2359 140 / jsimilak@sigmar.ie

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