Specialist, Quality Control M/F - 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.

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

• 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.

This position works out of our Victoriaville, QC location in the Established Pharmaceuticals division (EPD).

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).

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

• 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;
• Embeds and drives appropriate risk-based decision making;
• 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.

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;

• 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;
• 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.

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.

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.

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.

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;
• 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;
• 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.

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;

• 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.,);
• Posséder d'excellentes compétences en communications orales et écrites en français et en anglais;
• Visitez notre site ou suivez-nous sur Facebook, à et Twitter @AbbottNews et @AbbottGlobal.

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.

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

• 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.

This position works out of our Victoriaville, QC location in the Established Pharmaceuticals division (EPD).

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).

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

• 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;
• Embeds and drives appropriate risk-based decision making;
• 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.

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;

• 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;
• 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.
Operations Quality


DIVISION:

WORK SHIFT:
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MEDICAL SURVEILLANCE:

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.

They push the boundaries to help manage and treat some of life's greatest health challenges.
An equal opportunity employer, Abbott welcomes and encourages diversity in our workforce.
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