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Human Resources
Dublin City University

+353-1-7005000

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Details

Qualified Person (QP, part-time)


Reference:dcuqppt1 Location: Dublin
Qualification:DegreeExperience:See description
Job Type:Part-TimeSalary: See description
May be suitable for: Qualified Person
ICNT is a multi-disciplinary, internationally-competitive and well-funded Centre whose research focuses on developing novel, long-acting biotherapeutics for chronic pain. Recent advances include generation of potent and selective protein inhibitors of neuroexocytosis that give prolonged relief of neuropathic pain in rodents. These unique and promising recombinant anti-nociceptives are to be produced in a new ‘state-of-the-art’ GMP facility for evaluation in man.

Now that the GMP facility is constructed and functional, the post is required for hands-on, long term operation of the facility for future production of GMP grade therapeutics.


Key roles:

QP is to be named on the application to the Health Products Regulatory Authority (HPRA) for accreditation of a GMP facility and licence to manufacture an Investigational Medicinal Product (IMP). The appointee will oversee development, with the requisite team members, of a HPRA-acceptable Quality Management System, carry out GMP audits and be responsible for release of IMP batches for human use, according to the EU Guide to GMP.

Qualifications:

QP: compatible with the education and experience specified for IMP for clinical use in Directive 2001/83/EC as amended. An in-depth knowledge of GMP requirements and relevant industrial experience to competently perform the roles.

Duration: One year in the first instance; there may be an opportunity for longer contracts, subject to DCU recruitment & selection procedures.

Salary range: QP up to €90,000 p.a. pro rata (subject to qualifications and experience)

Closing date: 7th March 2016

Informal initial enquiries: Contact Prof. J. Oliver Dolly, Director of ICNT; Tel: +353 (0)1 700 7757 or E-mail: oliver.dolly@dcu.ie; and include C.V. plus names of 3 referees.

Application procedure: Application forms are available from the DCU Current Vacancies (Open Competitions) website at http://www4.dcu.ie/hr/vacancies/current.shtml, and from the Human Resources, Dublin City University, Dublin 9. Tel: +353 (0)1 700 5149; Fax: +353 (0)1 700 5500 or E-mail: hr.applications@dcu.ie to which completed applications should be submitted by E-mail, Fax or Post.

Dublin City University is an equal opportunities employer