Job Description

R\xc3\xa9sum\xc3\xa9

L\xe2\x80\x99auditeur AQ 2 est consid\xc3\xa9r\xc3\xa9 comme un r\xc3\xb4le de soutien crucial, car il fournit les moyens de surveiller en interne le syst\xc3\xa8me de gestion de la qualit\xc3\xa9 (QMS) en place. L\'auditeur AQ travaillera directement sous la supervision d\'un coll\xc3\xa8gue exp\xc3\xa9riment\xc3\xa9 en mati\xc3\xa8re d\xe2\x80\x99audit ou du gestionnaire de l\'AQ. Au fur et \xc3\xa0 mesure que l\'auditeur acquiert des comp\xc3\xa9tences et de l\xe2\x80\x99exp\xc3\xa9rience, il se voit confier des t\xc3\xa2ches suppl\xc3\xa9mentaires, deviendra ind\xc3\xa9pendant et assumera des responsabilit\xc3\xa9s envers les autres. L\'objectif principal de ce poste est d\'agir en tant qu\'auditeur coh\xc3\xa9rent et pr\xc3\xa9cis pour les \xc3\xa9tudes/projets r\xc3\xa9glement\xc3\xa9s ainsi que pour les processus g\xc3\xa9n\xc3\xa9raux.

Devoirs et responsabilit\xc3\xa9s:

L\'auditeur AQ devra :

• R\xc3\xa9viser les proc\xc3\xa9dures internes (par exemple, les SOP, les proc\xc3\xa9dures de m\xc3\xa9thode, etc.) pour s\xe2\x80\x99assurer de leur coh\xc3\xa9rence et de leur conformit\xc3\xa9 \xc3\xa0 la r\xc3\xa9glementation;
• R\xc3\xa9viser tous les enregistrements n\xc3\xa9cessaires \xc3\xa0 la reconstruction des donn\xc3\xa9es, y compris les enregistrements sp\xc3\xa9cifiques \xc3\xa0 l\'\xc3\xa9tude/au projet, la formation, l\'\xc3\xa9quipement, les installations, les enregistrements du syst\xc3\xa8me informatis\xc3\xa9, etc. ;
• R\xc3\xa9viser les donn\xc3\xa9es non li\xc3\xa9es \xc3\xa0 l\'\xc3\xa9tude/au projet ;
• R\xc3\xa9viser les livrables relatifs au cycle de vie des \xc3\xa9quipements et des syst\xc3\xa8mes informatis\xc3\xa9s ;
• Aider la direction (agir en tant que rempla\xc3\xa7ant) \xc3\xa0 archiver les documents/enregistrements conform\xc3\xa9ment aux proc\xc3\xa9dures internes et aux exigences r\xc3\xa9glementaires, ce qui comprend la gestion du mat\xc3\xa9riel archiv\xc3\xa9 et des archives physiques ;
• Suivre et conserver les documents contr\xc3\xb4l\xc3\xa9s tout au long de leur cycle de vie conform\xc3\xa9ment aux exigences proc\xc3\xa9durales et superviser leur distribution externe.

L\'auditeur AQ devra r\xc3\xa9guli\xc3\xa8rement et de mani\xc3\xa8re ind\xc3\xa9pendante :

• Suivre les proc\xc3\xa9dures internes \xc3\xa9tablies et les exigences sp\xc3\xa9cifiques du plan d\'\xc3\xa9tude/projet ;
• Maintenir une solide compr\xc3\xa9hension des exigences relatives \xc3\xa0 la r\xc3\xa9alisation d\'\xc3\xa9tudes/projets r\xc3\xa9glement\xc3\xa9s ;
• S\'efforcer continuellement de rester inform\xc3\xa9 des r\xc3\xa9glementations actuelles et des tendances de l\'industrie ;
• Effectuer des audits de qualifications de m\xc3\xa9thodes, de validations, d\'\xc3\xa9tudes/projets d\'essais sur \xc3\xa9chantillons ;
• \xc3\x89valuer de mani\xc3\xa8re critique les facteurs qui affectent l\'int\xc3\xa9grit\xc3\xa9 et la qualit\xc3\xa9 des donn\xc3\xa9es de l\'\xc3\xa9tude ;
• Effectuer des audits des processus et proc\xc3\xa9dures de routine du laboratoire et des installations ;
• Rapporter avec pr\xc3\xa9cision les conclusions de l\'audit, de mani\xc3\xa8re claire et succincte, conform\xc3\xa9ment aux exigences proc\xc3\xa9durales ;
• Identifier les domaines d\'am\xc3\xa9lioration et d\'efficacit\xc3\xa9 et les signaler \xc3\xa0 la direction ;
• Interagir de mani\xc3\xa8re constructive avec les coll\xc3\xa8gues et les clients ;
• Ex\xc3\xa9cuter d\'autres t\xc3\xa2ches assign\xc3\xa9es par la direction en faisant preuve de flexibilit\xc3\xa9 et d\xe2\x80\x99esprit critique ;
• Signaler \xc3\xa0 la direction tout probl\xc3\xa8me/risque potentiel li\xc3\xa9 \xc3\xa0 la qualit\xc3\xa9, \xc3\xa0 la conformit\xc3\xa9 et \xc3\xa0 l\'int\xc3\xa9grit\xc3\xa9 des donn\xc3\xa9es ;
• Participer \xc3\xa0 l\'analyse des causes profondes et \xc3\xa0 d\'autres activit\xc3\xa9s de r\xc3\xa9solution de probl\xc3\xa8mes ou d\'enqu\xc3\xaate afin de garantir la mise en \xc5\x93uvre d\xe2\x80\x99actions correctives/pr\xc3\xa9ventives efficaces et l\xe2\x80\x99am\xc3\xa9lioration des processus;
• Aider la direction \xc3\xa0 former le personnel ;
• Aider la direction dans l\xe2\x80\x99ex\xc3\xa9cution des audits des fournisseurs et des sous-traitants.

Qualifications

• Baccalaur\xc3\xa9at dans une discipline scientifique ou m\xc3\xa9dicale, de pr\xc3\xa9f\xc3\xa9rence en biologie ou biochimie, ou \xc3\xa9quivalent, combin\xc3\xa9 au nombre d\'ann\xc3\xa9es d\'exp\xc3\xa9rience requis dans un r\xc3\xb4le d\'assurance qualit\xc3\xa9, de pr\xc3\xa9f\xc3\xa9rence dans un environnement pharmaceutique/CRO ;
• Une bonne compr\xc3\xa9hension des r\xc3\xa9glementations et documents d\'orientation locaux et internationaux applicables, tels que les BPC (bonnes pratiques cliniques) et les BPL (bonnes pratiques de laboratoire) ainsi que les lignes directrices GCLP (bonnes pratiques de laboratoire clinique) ;
• Connaissance fondamentale des techniques de tests immunologiques et des activit\xc3\xa9s de laboratoire dans un environnement r\xc3\xa9glement\xc3\xa9 ;
• Parfaitement bilingue en anglais et en fran\xc3\xa7ais (\xc3\xa0 l\'oral et \xc3\xa0 l\'\xc3\xa9crit) ;
• Excellentes comp\xc3\xa9tences en communication verbale et \xc3\xa9crite et en relations interpersonnelles ;
• Capacit\xc3\xa9 \xc3\xa0 accomplir les t\xc3\xa2ches en temps opportun ;
• Excellentes comp\xc3\xa9tences multit\xc3\xa2ches et capacit\xc3\xa9 \xc3\xa0 g\xc3\xa9rer des priorit\xc3\xa9s changeantes pour respecter des d\xc3\xa9lais critiques dans un environnement dynamique et au rythme rapide ;
• Un sens aigu de l\'int\xc3\xa9grit\xc3\xa9 et de l\'\xc3\xa9thique;
• Capacit\xc3\xa9 \xc3\xa0 appliquer des commentaires constructifs pour am\xc3\xa9liorer les performances ;
• Excellentes comp\xc3\xa9tences informatiques dans la suite Microsoft Office.

Summary
QA Auditor 2 is considered a crucial support role in providing the means to internally monitor the Quality Management System (QMS) in place. The QA Auditor will initially work directly under the supervision of an experienced auditing colleague or the Manager, QA. As the Auditor matures in skill and proficiency, they will take on additional assignments, independence, and responsibilities for others. The major focus of this position is to act as a consistent and accurate auditor for regulated studies/projects as well as for general processes.

Duties and Responsibilities:

The QA Auditor will:

• Review internal procedures (e.g. SOPs, method procedures, etc.) for consistency and regulatory compliance;
• Review any records necessary for data reconstruction including study/project specific records, training, equipment, facility, computerized system records, etc.;
• Review non-study/project related data;
• Review equipment and computerized system lifecycle deliverables;
• Assist management (act as backup) to archive documents/records according to internal procedures and regulatory requirements which includes management of archived material and physical archives;
• Track and maintain controlled documents throughout their lifecycle as per procedural requirements and oversee their external distribution.

The QA Auditor will routinely and independently:

• Follow established internal procedures and study/project specific plan requirements;
• Maintain a solid understanding of requirements for conducting regulated studies/projects;
• Continuously strive to remain knowledgeable of current regulations and industry trends;
• Conduct audits of method qualifications, validations, sample testing studies/projects;
• Critically assess factors that affect the integrity and quality of study data;
• Conduct audits of routine processes and procedures of the laboratory and facilities;
• Accurately report audit findings in a clear and succinct manner according to procedural requirements;
• Identify areas of improvement and efficiencies and report these to management;
• Interact constructively with co-workers and clients;
• Execute other duties as assigned by management with flexibility and critical thinking;
• Escalate any potential issues/risks associated to quality, compliance and data integrity to management;
• Participate in root-cause analysis and other problem solving/investigation activities to ensure that effective corrective/preventive actions are implemented and processes are improved;
• Assist management to train personnel;
• Assist management to execute vendor and subcontractor audits.

Qualifications

• Bachelor\xe2\x80\x99s degree in a scientific or medical discipline, preferably in biology or biochemistry, or equivalent, combined with the required number of years of experience (refer to Career Ladder below) in quality assurance role, preferably in a pharmaceutical/CRO setting;
• A good understanding of applicable local and international regulations and guidance documents, such as GCP (Good Clinical Practices) and GLP (Good Laboratory Practices) and of GCLP (Good Clinical Laboratory Practices) guidelines;
• Fundamental knowledge of immunology testing techniques and laboratory activities within a regulated environment;
• Fluently bilingual in English and French (both oral and written);
• Excellent verbal and written communication and interpersonal skills;
• Ability to complete tasks in a timely manner;
• Excellent multi-tasking skills and ability to manage shifting priorities to meet critical deadlines in a fast paced and dynamic environment;
• A strong sense of integrity and ethics;
• Ability to apply constructive feedback to improve performance;
• Excellent computer skills in the Microsoft Office Suite.

Q\xc2\xb2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions.

IQVIA