Spécialiste de la qualité - Victoriaville, QC, Canada - Abbott Laboratories

Description

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

• Career development with an international company where you can grow the career you dream of.

• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Victoriaville, QC location in the Established Pharmaceuticals division (EPD). In this division, we are committed to bringing the benefits of our trusted medicines to more people in the world's fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory.

Reporting to the Director of Quality Assurance, the Quality Specialist is responsible for supporting the PQR (Product Quality Review) and monitoring reviews (water system, pest control, environmental monitoring, stability programs, compressed air system, cleaning program).

What You'll Do

• Develop and lead site relevant QA programs assuring continuity of supplies and successful execution of supplier qualification based on business needs;

• Provide QA expertise for the Lactulose and associated manufacturing supply chain;

• Drive investigation of product performance issues, providing solutions supporting the site, e.g. deficiency questions;

• Support execution of product/process improvements and compliance projects for all proposed manufacturing or regulatory changes;

• Embeds the technical expertise and knowledge in the operational QA team in Victoriaville on manufacturing, tests and release of Lactulose;

• Promotes continuous improvement, innovation, simplification aligned with Abbott and EPD strategy;

• Support the continuous improvement of the product(s) with cross-functional scope;

• Embeds and drives appropriate risk-based decision making;

• Maintain the Supplier Qualification Program;

• Assist the QA Director to complete the internal and external audit program;

• Execute and / or participate in internal and external quality audits;

• Support exception events and CAPA, from a technical QA perspective ensuring events are appropriately assessed for impact and documented;

• Support process changes which have a quality or regulatory impact, ensuring timely communication and implementation of changes in line with regulatory requirements;

• Support the PQR (Product Quality Review) and monitoring reviews (water system, pest control, environmental monitoring, stability programs, compressed air system, cleaning program);

• Support and replace Quality Specialists when absent.

Required Qualifications

• Bachelor's degree or equivalent level of education at a relevant scientific discipline or other technical/scientific, or industry experience with sufficient exposure to pharmaceutical or related industries;

• Comprehensive understanding of an Active Pharmaceutical Ingredient (API) Manufacturing and GMP's requirements;

• Experienced of the Pharmaceutical industries or GMP controlled industries;

• Knowledge of international and local quality system and compliance legislations and standards;

• Knowledge of Microsoft tools (Excel, Word, PowerPoint, etc.);

• Facility to use computerized systems;

• Excellent oral and written communication skills in French and English;

• Sense of organization, autonomy, and leadership.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is

JOB DESCRIPTION:

À propos d'Abbott

Abbott est un chef de file mondial de l'industrie des soins de santé qui crée des solutions scientifiques révolutionnaires visant à améliorer la santé des gens. L'entreprise est résolument tournée vers l'avenir, à l'affût des changements qui pourraient survenir dans le domaine des sciences et des technologies médicales.

Être à l'emploi d'Abbott

En étant à l'emploi d'Abbott, vous pourrez faire un travail qui compte, vous perfectionner et apprendre, prendre soin de vous et des membres de votre famille, rester fidèle à ce que vous êtes et vivre pleinement. Vous pourrez :

• profiter de possibilités d'avancement professionnel au sein d'une entreprise internationale qui vous permettra de bâtir la carrière dont vous rêvez;

• travailler pour une entreprise reconnue dans des douzaines de pays partout dans le monde comme étant un excellent milieu de travail et figurant parmi les entreprises les plus admirées dans le monde dans le classement Fortune;

• travailler pour une grande entreprise reconnue comme étant l'une des meilleures où travailler, notamment pour ce qui a trait à la diversité du personnel, à la conciliation travail-famille ainsi qu'à la place des femmes dans les postes de cadres et les postes scientifiques.

L'occasion à saisir

Nous cherchons à pourvoir un emploi à Victoriaville, au Québec, au sein de la division des produits pharmaceutiques établis (DPE). Dans cette division, nous nous engageons à apporter les avantages de nos médicaments de confiance à un plus grand nombre de personnes dans les pays à la croissance la plus rapide du monde. Notre vaste portefeuille de médicaments génériques de marque, différenciés et de haute qualité, couvre de nombreux domaines thérapeutiques, notamment la gastro-entérologie, la santé des femmes, les troubles cardiométaboliques, la gestion de la douleur et du système nerveux central, et les troubles respiratoires.

Relevant de la Directrice qualité, le spécialiste de la qualité sera responsable de fournir une expertise en AQ pour la fabrication de lactulose et la chaîne d'approvisionnement associée.

Ce que vous ferez

• Développer et diriger des programmes d'assurance qualité pertinents sur le site assurant ainsi la continuité de l'approvisionnement et de l'exécution réussie de la qualification des fournisseurs en fonction des besoins de l'entreprise;

• Diriger les enquêtes sur les problèmes de performance du produit, en fournissant des solutions soutenant le site, par exemple, des questions de carence;

• Soutenir l'exécution des projets d'amélioration et de conformité des produits et des processus pour toutes les modifications réglementaires et/ou de fabrications proposées;

• Intégrer l'expertise technique et les connaissances de l'équipe d'AQ opérationnelle à Victoriaville sur la fabrication, l'analyse et la libération de lactulose;

• Favoriser l'amélioration continue, l'innovation et la simplification alignées sur la stratégie d'Abbott et de DPÉ;

• Soutenir l'amélioration continue du ou des produits avec une portée interfonctionnelle;

• Gérer la prise de décisions appropriées basées sur le risque;

• Maintenir le programme de qualification des fournisseurs;

• Aider le directeur de l'AQ à bien exécuter le programme d'audit interne et externe (FDA);

• Exécuter et/ou participer à des audits de qualité internes et externes;

• Appuyer les événements d'exception et CAPA, du point de vue technique de l'AQ, en veillant à ce que l'impact des incidents soit évalué de manière appropriée et documentée;

• Établir les changements de processus qui ont un impact sur la qualité ou la réglementation, tout en assurant une communication en temps opportun et la mise en œuvre des changements conformément aux exigences réglementaires;

• Soutenir le PQR (Examen de la qualité des produits) et les examens de surveillance (système d'eau, lutte antiparasitaire, surveillance environnementale, programmes de stabilité, système d'air comprimé, programme de nettoyage);

• Remplacer le superviseur AQ - SQ et supporter le Spécialiste Assurance Qualité en cas d'absence.

Compétences requises

• Baccalauréat ou niveau d'études équivalent dans une discipline scientifique pertinente ou une autre expérience technique / scientifique ou de l'industrie avec une exposition suffisante aux industries pharmaceutiques ou connexes;

• Compréhension complète des exigences de fabrication d'ingrédients pharmaceutiques actifs (IPA) et de BPF;

• Expérience des industries pharmaceutiques ou des industries contrôlées par les normes GMP (BPF);

• Détenir les connaissances des systèmes de qualité internationaux et locaux et des lois et normes de conformité;

• Connaissance des outils de la Suite Microsoft Office (Excel, Word, PowerPoint, etc.,);

• Être familiarisé avec l'utilisation de systèmes informatisés;

• Posséder d'excellentes compétences en communications orales et écrites en français et en anglais;

• Avoir le sens de l'organisation, de l'autonomie et du leadership.

Réalisez vos aspirations professionnelles en saisissant diverses occasions de carrière chez Abbott, une entreprise qui peut vous aider à bâtir votre futur et vivre au meilleur de vos possibilités. Abbott est un employeur souscrivant au principe de l'égalité d'accès à l'emploi et ayant à cœur de favoriser la diversité au sein de sa main-d'œuvre.

Visitez notre site ou suivez-nous sur Facebook, à et Twitter @AbbottNews et @AbbottGlobal.

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people's health. We're always looking towards the future, anticipating changes in medical science and technology.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You will have access to:

• Career development with an international company where you can grow the career you dream of.

• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.

• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This position works out of our Victoriaville, QC location in the Established Pharmaceuticals division (EPD). In this division, we are committed to bringing the benefits of our trusted medicines to more people in the world's fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory.

Reporting to the Director of Quality Assurance, the Quality Specialist is responsible for supporting the PQR (Product Quality Review) and monitoring reviews (water system, pest control, environmental monitoring, stability programs, compressed air system, cleaning program).

What You'll Do

• Develop and lead site relevant QA programs assuring continuity of supplies and successful execution of supplier qualification based on business needs;

• Provide QA expertise for the Lactulose and associated manufacturing supply chain;

• Drive investigation of product performance issues, providing solutions supporting the site, e.g. deficiency questions;

• Support execution of product/process improvements and compliance projects for all proposed manufacturing or regulatory changes;

• Embeds the technical expertise and knowledge in the operational QA team in Victoriaville on manufacturing, tests and release of Lactulose;

• Promotes continuous improvement, innovation, simplification aligned with Abbott and EPD strategy;

• Support the continuous improvement of the product(s) with cross-functional scope;

• Embeds and drives appropriate risk-based decision making;

• Maintain the Supplier Qualification Program;

• Assist the QA Director to complete the internal and external audit program;

• Execute and / or participate in internal and external quality audits;

• Support exception events and CAPA, from a technical QA perspective ensuring events are appropriately assessed for impact and documented;

• Support process changes which have a quality or regulatory impact, ensuring timely communication and implementation of changes in line with regulatory requirements;

• Support the PQR (Product Quality Review) and monitoring reviews (water system, pest control, environmental monitoring, stability programs, compressed air system, cleaning program);

• Support and replace Quality Specialists when absent.

Required Qualifications

• Bachelor's degree or equivalent level of education at a relevant scientific discipline or other technical/scientific, or industry experience with sufficient exposure to pharmaceutical or related industries;

• Comprehensive understanding of an Active Pharmaceutical Ingredient (API) Manufacturing and GMP's requirements;

• Experienced of the Pharmaceutical industries or GMP controlled industries;

• Knowledge of international and local quality system and compliance legislations and standards;

• Knowledge of Microsoft tools (Excel, Word, PowerPoint, etc.);

• Facility to use computerized systems;

• Excellent oral and written communication skills in French and English;

• Sense of organization, autonomy, and leadership.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

Connect with us at on Facebook at and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is

In specific locations, the pay range may vary from the range posted.

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Abbott is about the power of health. For more than 135 years, Abbott has been helping people reach their potential — because better health allows people and communities to achieve more. With a diverse, global network serving customers in more than 160 countries, we create new solutions — across the spectrum of health, around the world, for all stages of life. Whether it's next-generation diagnostics, life-changing devices, science-based nutrition, or novel reformulations, we are advancing some of the most innovative and revolutionary technologies in healthcare, helping people live their best lives through better health.

The people of Abbott come to work each day with relentless energy, enthusiasm and a promise to enhance the health and well-being of millions of people. They push the boundaries to help manage and treat some of life's greatest health challenges.

We invite you to explore opportunities at Abbott , to see if your talents and career aspirations may fit with our openings. An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.