On behalf of our client, we are currently recruiting for a Blood, Tissues & Organs (BTO) Inspector. This is for a Maternity Contract cover role of approx 9 months duration. The person must have their own vehicle and be flexible for travel.
ROLE SUMMARY
Reporting to the Blood, Tissues & Organs (BTO) Manager, the Inspector will be primarily responsible for assessing the compliance of blood establishments, tissue establishments, organ procurement centres and organ transplant centres, with the requirements of European and National legislation and associated good practice guidelines.
The content below represents a broad guideline for the role of Inspector. Some aspects may be subject to change in accordance with business needs.
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:
o Blood Establishments o Tissue Establishments o Organ Procurement Centres o Organ Transplantation Centres o Manufacturers of advanced therapy medicinal products
The role involves inspecting, reporting and forming conclusions in respect of the suitability of a site for the activities which it has sought authorisation or is already authorised for. The standards that apply include:
o Good Practice guidance for tissues and cells, including relevant European Commission and Council of Europe guidance.
o Good Practice guidance for blood and blood components, including relevant European Commission and Council of Europe guidance.
o National and European guidelines in relation to organ procurement and transplantation. o Good Manufacturing Practice (GMP); Good Distribution Practice (GDP); Good Laboratory Practice.
The Inspector will provide technical information and advice to relevant individuals and organisations.
The Inspector will participate in the review and assessment of annual reports received from stakeholders.
The inspector will interact and provide relevant input into the continued development of systems relevant to the Inspections section.
QUALIFICATIONS AND EXPERIENCE
- To be considered for this post, candidates must have:
o 3rd level degree in a relevant scientific or related discipline
o A minimum of three years’ relevant experience working in any of the following areas:
o The donation, collection, testing, processing and distribution of blood and blood components
o The donation, procurement, testing, processing and distribution of tissues and cells for human application
o The procurement and transplantation of organs o Performing inspections of blood establishments, tissue establishments, or organ procurement or transplant centres.
o Performing audits of hospital blood banks.
o A facility that manufacturers biotech medicines.
o Knowledge of relevant European and National legislation
o Relevant technical knowledge and quality system experience
o A full valid EU driving licence and access to a vehicle
o Excellent communication and report writing skills
o Proven ability to gather information and apply analytical skills to reach decisions on technical issues
o A proven track record of working within a multi-disciplinary team
o A proven ability to work unsupervised
- In addition to this the ideal candidate will have;
o A postgraduate qualification in a relevant scientific or related discipline
o Experience working in the following areas:
The manufacture and / or quality assurance of biotech medicines, sterile medicinal products, medical devices and/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; assisted human reproduction (AHR)
o A knowledge of validation requirements (including facility and equipment qualification and process, computer and assay validation)
o Ability to be flexible, manage workload and to show initiative when required o Experience in the use of Quality Risk Management principles and tools
- Availability to travel for national and international inspections or meetings is a requirement in this role
For full details contact Linda at +353 1 2784701 or email your CV to [email protected]. Thornshaw Scientific is a division of the CPL Group www.thornshaw.com
