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Details

Blood Tissue and Organ Inspector


Reference:SC/HQ00001483 Location: Dublin
Qualification:DegreeExperience:3-4 Years
Job Type:Fixed Term ContractSalary: Not Disclosed

Blood Tissue and Organ Inspector
Our client are currently recruiting for a Blood Tissue and Organ Inspector to join their team. As Blood Tissue and Organ Inspector you will be responsible for assessing the compliance of organ procurement centres, organ transplant centres, blood establishments and tissue establishments with the requirements of European and National legislation and associated good practice guidelines.

The role of an Inspector is to evaluate the compliance of sites inspected, in Ireland and abroad, with the requirements of National legislation (in Ireland), European Directives, Regulations and relevant guidance
These sites may include: Organ Procurement Centres , Organ Transplantation Centres ,Tissue Establishments , Blood Establishments and Manufacturers of advance therapy medicinal products.


Responsibilities
• Provide technical information and advice to relevant individuals and organisations both internal and external to the Regulatory Authority
• Provide support to the development and execution of national regulations in relation to, blood, tissues and cells and organs
• Participate in the review and assessment of annual reports received from stakeholders
• Interact and provide relevant input into the continued development of vigilance systems relevant to the Blood, Tissues and Organs section
• Preparing for, organising and carrying out inspections in accordance with the organisations procedures
• Write inspection reports when acting as lead inspector and contributing to preparation of reports for joint or accompanied inspections
• Assisting in the compilation of data and preparation of technical and management reports as required
• Applying risk management principles
• Submitting reports as required and maintaining appropriate records of meetings and activities
• Updating databases in place for the management of workflow in the organisation
• Assist in the development and implementation of policy and good practice guidelines

Requirements
• Degree in a relevant life sciences discipline
• Postgraduate qualification in a relevant life sciences discipline
• A minimum of three years relevant work experience working in either an Organ Procurement Centre or Transplantation Centre, in a Blood or Tissue Establishment, or hospital blood bank or in a related regulatory environment with relevant technical knowledge and quality system experience
• Full driving licence and car
• Evidence of excellent communication and report writing skills
• Evidence of effective decision making and planning and organisation skills
• Experience in the manufacture and or quality assurance of biotech medicines, sterile medicinal products, and medical devicesand/or cell based medicinal products; a relevant hospital laboratory setting; adverse event and reaction reporting mechanisms; testing biological products; auditing; batch acceptance and approval of critical suppliers
• A thorough knowledge of validation requirements (including facility and equipment qualification and process, computer and assay validation)
• Experience of batch acceptance and approval of critical suppliers
• Experience in the use of Quality Risk Management principles and tools
• Availability to travel for national and international inspections is a requirement in this role


If you would like further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252