Spécialiste Qualité du Site/ Quality Site Specialist

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What you do at McKesson matters. We foster a culture where you can grow, make an impact, and are empowered to bring new ideas. Together, we thrive as we shape the future of health for patients, our communities, and our people. If you want to be part of tomorrow's health today, we want to hear from you.

Rsum du poste

Sous la responsabilit du Chef de la qualit principal, distribution pharmaceutique, le spcialiste qualit du site (QSS) est charg de veiller ce qu'un produit ou un service rponde aux normes de qualit tablies, notamment en matire de fiabilit, de facilit d'utilisation et de performance. Le/la titulaire du poste soutiendra les activits de distribution pharmaceutique au niveau du centre de distribution dans le cadre d'activits varies d'assurance de la qualit.

ce niveau, le/la spcialiste qualit sur site doit gnralement :

• Travailler sous une direction limite, le travail tant valu la fin pour s'assurer que les objectifs sont atteints
• Dterminer et laborer des approches de solutions.
• Il entretient des contacts frquents avec les clients externes et inter organisationnels.
• Reprsenter le service dans le cadre de projets et peut jouer un rle de chef de projet.
• Reprsenter le service et tre le principal point de contact en matire de qualit au niveau du centre de distribution.
• Rsoudre un large ventail de problmes complexes en faisant preuve de discernement dans le cadre de politiques et de pratiques dfinies.

Section A -Responsabilits Spcifiques

Certaines responsabilits typiquement associes un emploi de spcialiste de la qualit sont incluses dans la section B. Les tches spcifiques comprennent gnralement les lments suivants, sans toutefois s'y limiter :

• Excuter la qualification et la cartographie des quipements
• Excuter les protocoles de qualification
• Grer le systme de contrle de la temprature
• Rdiger des politiques et des procdures d'assurance qualit
• Interprter et mettre en uvre les normes d'assurance qualit
• valuer l'adquation des normes d'assurance qualit
• Examiner la mise en uvre et l'efficacit des systmes de qualit et d'inspection
• Planifier, raliser et surveiller les tests et l'inspection des matriaux et des produits afin de garantir la qualit du produit fini.
• Documenter les audits internes et autres activits d'assurance de la qualit
• Enquter sur les plaintes des clients et les problmes de non-conformit
• Collecter et compiler des donnes statistiques sur la qualit
• Analyser les donnes afin d'identifier les domaines d'amlioration du systme de qualit
• laborer, recommander et suivre des actions correctives et prventives
• Prparer des rapports pour communiquer les rsultats des activits lies la qualit
• Coordonner et soutenir les audits sur site mens par des agences externes
• valuer les rsultats des audits et mettre en uvre les actions correctives appropries
• Contrler les activits de gestion des risques

Section B - Responsabilits gnrales

• Promouvoir la comprhension des normes et processus de qualit auprs des directeurs de la distribution dans le centre de distribution.
• Identifier les besoins en formation et organiser des interventions de formation pour rpondre aux normes de qualit.
• Assurer la prparation, l'excution et le suivi des inspections rglementaires en tenant jour le dossier d'inspection, en grant les documents d'audit et les actions fournies dans les rponses.

Section C - Exigences cls

Formation et exprience:

• Baccalaurat en chimie, biologie ou ou autres sciences
• 4+ annes d'exprience pertinente
• Bonnes aptitudes la communication, tant l'oral qu' l'crit, en anglais et en franais
• Exprience en matire d'inspection de la qualit, d'audit et de tests.
• Exprience dans l'excution de la qualification ou de la cartographie des quipements
• Exprience de la mise en uvre de programmes d'actions correctives
• Exprience spcifique un produit ou une industrie
• Solides comptences informatiques, y compris Microsoft Office, les applications d'assurance qualit et les bases de donnes
• Connaissance des outils, concepts et mthodologies d'AQ
• Connaissance des exigences rglementaires pertinentes.

Connaissances et comptences:

• Faire preuve d'un fort leadership dans un environnement professionnel
• La capacit grer le temps et hirarchiser les tches est une caractristique essentielle.
• Comptences en matire de communication - verbale et crite
• Collecte, gestion et analyse de donnes
• Analyse et rsolution de problmes.
• Planification et organisation
• Jugement
• Prise de dcision
• Orientation vers le service la clientle
• Capacit motiver dans un environnement de travail en quipe
• Capacit travailler sous une direction limite.

Le/la titulaire de ce poste aura soutenir de faon quotidienne des clients internes et/ou externes l'extrieur du Qubec et/ou aux tats-Unis. Par consquent, ce poste requiert une matrise de l'anglais l'crit et l'oral. Veuillez noter que le nombre de postes dont les tches requirent une connaissance de la langue anglaise a t restreint dans la mesure du possible.

Job Summary

Reporting to the Senior Manager, Quality, Pharmaceutical Distribution, the Quality Site Specialist (QSS), will be responsible for ensuring a product or service meets the established standards of quality including reliability, usability, and performance. The incumbent will support pharmaceutical distribution activities at the distribution centre level through various quality assurance activities.

At this level, the Quality Site Specialist typically:

• Works under limited direction with work being evaluated upon completion to ensure objectives are met
• Determines and develops approach to solutions.
• Frequent interorganizational and outside customer contacts.
• Represents the department on projects and may perform in project leadership role.
• Represent the department and is the main quality point of contact at the DC level.
• Provides resolutions to a diverse range of complex problems using judgement within defined policies and practices.

Section A - Specific Responsibilities

Certain responsibilities that are typically associated with a job as Quality Specialist are included in Section B. Specific duties generally include but are not limited to the following:

• Execute equipment qualification and mapping
• Execute qualification protocols
• Manage the temperature monitoring system
• Draft quality assurance policies and procedures
• Interpret and implement quality assurance standards
• Evaluate adequacy of quality assurance standards
• Review the implementation and efficiency of quality and inspection systems
• Plan, conduct and monitor testing and inspection of materials and products to ensure finished product quality
• Document internal audits and other quality assurance activities
• Investigate customer complaints and non-conformance issues
• Collect and compile statistical quality data
• Analyze data to identify areas for improvement in the quality system
• Develop, recommend and monitor corrective and preventive actions
• Prepare reports to communicate outcomes of quality activities
• Coordinate and support on-site audits conducted by external providers
• Evaluate audit findings and implement appropriate corrective actions
• Monitor risk management activities
• Responsible for document management systems
• Assure ongoing compliance with quality and industry regulatory requirements.

Section B - General Responsibilities

• Promotes understanding of quality standards and processes with Distribution Directors in the DC.
• Identify training needs and organize training interventions to meet quality standards
• Ensures proper preparation, execution and follow-up of Regulatory Inspections by maintaining the inspection file, managing audit documents and response actions.

Section C - Key Requirements

Education and Experience:

• B.SC. in Chemistry, Biology or other sciences
• 4+ years of relevant experience
• Good communication skills, both oral and written, in English and French
• Quality inspection, auditing and testing experience
• Experience in execution of equipment qualification or mapping
• Experience with implementation of corrective action programs
• Product or industry-specific experience
• Strong computer skills including Microsoft Office, QA applications and databases
• Knowledge of tools, concepts and methodologies of QA
• Knowledge of relevant regulatory requirements.

Knowledge and Skills:

• Demonstrate strong leadership in a professional environment
• Ability to manage time and prioritize tasks is an essential characteristic
• Communication skills - verbal and written
• Data collection, management and analysis
• Problem analysis and problem solving
• Planning and organizing
• Judgment
• Decision-making
• Customer service orientation
• Ability to motivate in a teamwork environment
• Capacity to work under limited direction.
• #LI-JT2

The incumbent of this position will provide daily support to internal and/or external clients outside Quebec and/or in the United States. Therefore, he/she must be proficient in spoken and written English. Please note that the number of positions requiring English language skills has been limited where possible.

We are proud to offer a competitive compensation package at McKesson as part of our Total Rewards. This is determined by several factors, including performance, experience and skills, equity, regular job market evaluations, and geographical markets. The pay range shown below is aligned with McKesson's pay philosophy, and pay will always be compliant with any applicable regulations. In addition to base pay, other compensation, such as an annual bonus or long-term incentive opportunities may be offered. For more information regarding benefits at McKesson, please click here.

Our Base Pay Range for this position

$68,000 - $113,400

McKesson is an Equal Opportunity Employer

McKesson provides equal employment opportunities to applicants and employees and is committed to a diverse and inclusive environment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age or genetic information. For additional information on McKesson's full Equal Employment Opportunity policies, visit our Equal Employment Opportunity page.

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