Our client is looking for a Qualified Person (IMP). The Qualified Person will be the named on the companys Pharmaceuticals Manufacturing and Import Authorisation (MIA) for Investigational Medicinal Products (IMP) under the direction of the Head of IMP-QP & SM GMP Clinical QA EU QP certification activities with responsibility for IMP in accordance with their Clinical Trial Authorisations (national or European), their IMP Dossiers and their Manufacturing Authorisations and the principles and guidelines of GMP as laid down in Directive 2003/94/EC and in accordance with principles and the detailed guidelines for Good Manufacturing Practice (GMP) for Medicinal Products (The Rules Governing Medicinal Products in The European Community, Volume IV).
The QP will provide QA /QP support for work performed at contract manufacturers and analytical laboratories, and coordinate priorities and workload with key stakeholders.
The QP will be responsible for the successful, timely completion of goals and objectives which will strengthen EU Clinical QA operations.
Certify that batches of finished products to be released in the EC/EEA have been manufactured and checked in accordance with the Clinical Trials Authorization (CTA), GMP, Product Specification File and legal requirements as set out in Article 51 of directive 2001/83/EC and article 13.3 of 2001/20/EC.
Assure drug product, documentation, and data related to the manufacturing, packaging, labelling, and testing of IMPs are compliant with all GMP, SOP, CTA, and regulatory requirements.
Audit Contractor/Supplier facilities associated with released products, when required to ensure they have effective quality systems in place to assure compliance with the
principles of GMP, as laid down in the relevant EC or national laws and guidelines.
Foster communication with key stakeholders in order to properly plan and prioritise workload and to coordinate technical information and queries.
To coordinate and participate in meetings that support of department objectives.
Foster the use of the Project Based Approach to record all documents that are needed to release material for a clinical study.
Ensure deviations and OOS investigations are adequately investigated and documented. To ensure clinical complaints are adequately investigated and reported.
Education & Experience Requirements
Eligibility to act as a Qualified Person in line with local and EU directives.
Bachelor?s degree in chemistry, biology, pharmacy or a related science discipline Experience working in Quality Assurance supporting the manufacturing/packaging of drugs, biologics, or devices.
Working knowledge and understanding of quality systems and GMPs.
Operational experience and technical understanding of standard manufacturing and packaging processes for a variety of dosage forms.
Experience working with ERP applications.
Must be able to read, understand, speak and write technically and legibly in English
Must be able to critically evaluate completed manufacturing documentation and assess to determine compliance with SOPs and clinical trial authorisations.
Experience working with contract manufacturing organisations (CMO) GMP Auditing experience.
Experience interfacing with regulatory bodies or working on regulatory submissions.
High level of professional competence.
Preferably demonstrated by objective certification (e.g. Certified Quality Auditor or Engineer). Some travel required for audits and other quality related visits. Some overseas travel may be required.
For further information on this Qualified Person - Investigational Medicinal Products (IMP) position please contact Laurentina Kennedy at The RFT Group on 01 2302400 Check out all our open jobs on our Recruitment website: www.rftgroup.ie
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