On behalf of my client, we are working with them on a new opportunity for a Quality Defects and Recall Inspector.
The role involves performing risk-based technical evaluations and assessments of suspected and confirmed Quality Defect reports on medicines and active substances, and performing for-cause GMP and other inspections, as required, in relation to serious QDR issues.
The Inspector reviews and/or recommends actions that are designed to remediate and correct the non-compliance issue at hand, to ensure patient and animal safety.
The QDR Inspector works closely with the other members of the QDR team and provides technical support to the Scientific Officers in the QDR area, as well as to other members of the Market Compliance section and the Compliance department as a whole.
The QDR Inspector maintains effective working relationships with colleagues in other sections and departments and with external stakeholder groups, to ensure that QDR issues requiring cross-functional and external input are effectively investigated and followed up.
QUALIFICATIONS AND EXPERIENCE
To be considered for this post, candidates must have:
o A 3rd level (honours) degree in a relevant scientific or related discipline
o A minimum of three years of relevant experience in one or more of the following:
o A facility that manufactures medicinal products
o A Regulatory Authority - working as an investigator of quality defects in medicinal products or as a GMP Inspector or in pharmaceutical assessment, or in another relevant area
o A Retail or Hospital Pharmacy – working as a dispensing pharmacist
o An excellent working knowledge of the EU GMP requirements, particularly those elements relating to the Pharmaceutical Quality System, Quality Defect/Complaint investigations, Root Cause Analysis and CAPA (Corrective Actions and Preventative Actions).
o A good working knowledge of Quality Risk Management
o A proven ability to work unsupervised and in a leadership role.
o A proven ability to work with others in a collaborative and solutions-focused manner.
o A proven ability to work effectively as part of a multi-disciplinary team
Note: Availability to travel for national and international inspections is a requirement in this role.
For full details contact Tina by sending your CV to firstname.lastname@example.org or call +353 1 2784701
Thornshaw Scientific is a division of the CPL Group www.thornshaw.com