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Qualified Person

Reference:BC/HQ00001909
Location: Dublin West
Qualification:Masters
Experience:4-5 Years
Job Type:Permanent
Salary:€80000 - €100000
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May be suitable for: Qualified Person

Our client is a leading global biotechnology company. They have best-in-class products in a number of therapeutic areas.
They are seeking a QP for a global role with diverse responsibilities and a clear career path. Experience in Biologics is an advantage. The position will require approximately up to 20% travel.

Responsibilities:
This position is responsible for the disposition of material, including QP certification of product and works closely with colleagues in the Quality organization providing oversight of contact manufacturers, testing
facilities and for leading, monitoring and supporting the quality performance of appropriate quality systems according GMP.
The QP is responsible for ensuring that medicinal products have been manufactured and tested in accordance with GMP and the products’ Marketing Authorizations.
The individual may be responsible for, but is not limited to:
Contact for HPRA regarding recall, inspection and Manufacturing Importation Authorisation (MIA)
Submitting license changes to the HPRA
License maintenance (MIA)
Maintenance of the QP batch register
Performing batch disposition
SOP Review / Approval
Participate in qualification of CMO’s and contact laboratories
Participate in the oversight of CMO’s and contact laboratories
Leading investigations
Reviewing and approving batch records, specifications, deviations and change controls
Designing, implementing and improving quality metrics and quality systems
Leading meetings and audits
Leading and facilitating technology transfer, process scale-up, and process improvement
projects.
Facilitating timely drug product complaint investigations
Reviewing and approving Annual Product Quality Reviews (AQPR).
Implementing, reviewing and maintaining Quality Agreements, as required
manner.

Requirements:
Eligible to work as a Qualified Person meeting the requirements of Article 49 of Directive
2001/83/EC of the European Parliament, as amended
Bachelor’s degree in chemistry, biology or a related discipline
People manager experience
Experience conducting audits as lead auditor
Quality experience in parenteral biological manufacturing (advantageous)

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

Brian Christensen | Tel: +353 (0) 1 685 4747




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