Quality Assurance & Compliance Specialist / Spécialiste de lassurance qualité et de la conformité
BioScript Solutions Career
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Empowering lives, healing hearts, embracing future
Are you ready to make a lasting impact in specialty care? We’re seeking a dedicated Quality Assurance & Compliance Specialist to join our #BestTeam at A&D Wholesale, where we put our people and patients first!
What we offer (and why you’ll love it here!):
- Epic Work-Life Balance: Our A&D Wholesale is Business Hours! Monday to Friday, no evening’s weekends or holidays.
- Growth Opportunities: Taking the passion for patient impact and using it in a specialty setting, in a company that champions learning and growth for team members.
- Vibrant Culture: Collaborative approach to provide endless support to patient care.
- Attractive Compensation: Robust and Comprehensive compensation and benefits, available from day 1!
- What & Where: Full Time, Permanent / Mississauga, ON
Why BioScript Solutions?
At BioScript, we're not just a company—we're a fast growing company always putting patients first. As pioneers in the specialty space, we believe in pushing boundaries, setting trends, and crafting experiences that captivate and inspire. Our vibrant team is made up of brilliant minds who are passionate about driving success and making an impact. Ready to be a part of this exhilarating journey?
Your mission:
- Ensure that all documentation systems (SOP’s, Forms and Diagrams) are in place and meet the legal/quality requirements.
- Perform periodic review of documents such as SOP reviews, Log reviews and others.
- Monitor, issue and retrieve controlled documents, and the dispositioning of superseded or obsolete documents.
- Ensure records are retained in accordance with A&D’s record retention policy and GMP requirements.
- Prepare and maintain logs and compliance records (e.g. change control, non-conformances, complaint log, destruction, etc.).
- Maintain and review the temperature monitoring devices and records and notify QAC Manager of any deviations, while conducting timely investigations of the same.
- Participate and assist as required in self-inspections, external (regulatory) and client audits.
- Assist in complaints/AEs, deviations, product returns, destructions, CAPAs, product recalls and validation of pack-outs and equipment as required.
- Assist/manage other special QA projects as needed.
- Responsible for managing employee training.
- Participate in cross functional training initiatives to ensure the Quality Departments overall business requirements are met.
What you bring to the table:
Education:
- Bachelor’s Degree in Science
Experience:
- Previous experience in a Quality Assurance related role preferred
Skills:
- Strong knowledge of GMPs and HC compliance requirements for the wholesaling and importation of pharmaceuticals.
- Excellent interpersonal, communication and presentation skills.
- Business acumen and the ability to work independently.
- Strong record keeping and time management skills.
- Requires minimal supervision and has the ability to work with multiple projects under tight deadlines.
- Proficiency in all Microsoft Office applications and ability to produce effective reports, documents and presentations.
- English proficiency is required for this position to effectively communicate with internal and external stakeholders.
- Bilingualism (French and English) may be required depending on the specific role, location, and the needs of the organization.
Compensation: At BioScript, your base pay is one part of your total compensation package and is determined within a range. Our pay ranges are based on the local cost of labor benchmarks for each specific role, level, and geographic location.
We're proud to be an equal opportunity employer. As a people-centric organization, we’re committed to fostering a welcoming culture free of discrimination, and to providing a healthy and safe work environment where all team members can thrive as individuals. Through our commitment to diversity, inclusion, belonging, and equity, we strive to provide an accessible workplace, where individuals feel valued, respected, and supported every day.
We are committed to creating an inclusive and accessible work environment across Canada. In accordance with applicable provincial legislation, including Quebec’s Charter of the French Language, this job posting is provided in both French and English when required. For positions based in Quebec, French language proficiency is required to perform day-to-day duties.
We encourage and accept all applications, however, only candidates selected for interviews will be contacted. Accommodations can be made available on request for candidates taking part in all aspects of the selection process. For inquiries, please email the talent acquisition team at View email address on jobs.jobcopilot.com.
Ready to make your mark? If you’re passionate about transforming ideas into extraordinary results and excited to join a forward-thinking team, we want to hear from you!
#INDA
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Améliorer les vies, guérir les cœurs et accueillir l’avenir
Est-ce que vous vous sentez d’attaque pour faire votre marque dans le domaine des soins spécialisés? Nous sommes à la recherche d’une personne dévouée qui souhaite se joindre à notre #MeilleureÉquipe et occuper le poste de spécialiste de l’assurance qualité et de la conformité au grossiste A&D, où nous accordons la priorité à notre équipe et aux patientes et patients!
Ce que nous offrons (et ce qui fera que vous aimerez travailler avec nous!)
- Excellent équilibre travail-vie personnelle : L’équipe du grossiste A&D travaille lors des heures de travail normales! Du lundi au vendredi, aucun travail les soirs, les fins de semaine, ni les jours fériés.
- Possibilités de croissance : Nous appliquons notre passion pour améliorer le mieux-être des patients dans un contexte de soins spécialisés et nous promouvons l’apprentissage et le perfectionnement auprès des membres de l’équipe.
- Culture dynamique : Nous adoptons une approche collaborative afin de fournir un soutien indispensable aux soins aux patients.
- Rémunération attrayante : nous offrons de la rémunération et des avantages sociaux concurrentiels et complets dès le premier jour de travail!
- Détails et lieu de l’emploi : Poste permanent à temps plein, Mississauga, Ontario
Pourquoi choisir BioScript Solutions?
BioScript n’est pas qu’une simple entreprise; elle est une entreprise en forte croissance qui accorde toujours la priorité aux patients. En tant que visionnaires du secteur des soins spécialisés, nous croyons en l’importance de repousser les limites, d’établir des tendances et de créer des expériences significatives, captivantes et inspirantes. Notre équipe dynamique est composée de personnes innovatrices qui ont une passion pour le succès et qui souhaitent faire bouger les choses. Pourquoi ne pas vous joindre à nous dans notre aventure exaltante?
Votre mission
- Assurer que tous les systèmes de documentation (PON, formulaires et schémas) sont en place et répondent aux exigences juridiques et de qualité.
- Effectuer une revue périodique des documents tels que les PON, les journaux de bord et autres.
- Assurer le suivi, l’émission et la récupération des documents contrôlés, ainsi que l’élimination des documents remplacés ou obsolètes.
- Assurer que les dossiers sont conservés en conformité avec la politique de la conservation des dossiers du Grossiste A&D et avec les exigences des BPF.
- Préparer et tenir à jour les journaux et les dossiers de conformité (p. ex. le contrôle des changements, les non-conformités, les journaux de plaintes, les destructions, etc.)
- Assurer l’entretien et la vérification des dispositifs de surveillance de la température et des registres associés, et signaler toute déviation au gestionnaire de l’assurance qualité et de la conformité, tout en menant des enquêtes en temps opportun à ce sujet.
- Participer aux auto-inspections, aux audits externes (réglementaires) et aux audits des clients, et fournir le soutien nécessaire au besoin.
- Assister en cas de plaintes/d’EI, de déviations, de retours de produit, de destructions, de demandes CAPA, de rappels et de validations des emballages et du matériel, le cas échéant.
- Gérer ou aider à la gestion d’autres projets spéciaux en matière d’assurance qualité, au besoin.
- Gérer les formations des employées et employés.
- Participer aux initiatives de formation interfonctionnelles pour veiller au respect des exigences opérationnelles globales des services de qualité.
L’expérience que vous apportez
Formation
- Détenir un baccalauréat en sciences.
Expérience
- Avoir une expérience précédente dans un rôle lié à l’assurance qualité est une préférence.
Aptitudes
- Posséder des connaissances approfondies au sujet des BFP et des exigences de la conformité de Santéâ¯Canada pour le commerce de gros et pour l’importation des produits pharmaceutiques.
- Avoir d’excellentes compétences en matière de relations interpersonnelles, de communication et de présentation.
- Avoir un sens aigu pour les affaires et la capacité de travailler en autonomie.
- Avoir d’excellentes compétences en tenue des dossiers et en gestion du temps.
- Être capable de travailler avec peu d’encadrement et de mener plusieurs projets dans des délais serrés.
- Avoir une bonne maîtrise de toutes les applications de la suite bureautique Microsoft Officeâ¯et être capable de produire des rapports, des documents et des présentations efficaces.
- Avoir une bonne maîtrise de l’anglais est nécessaire dans le cadre de ce poste afin de communiquer efficacement avec les parties prenantes internes et externes.
- Être bilingue (français et anglais) peut être nécessaire selon le rôle, l’emplacement et les besoins précis de l’entreprise.
Rémunération : Chez BioScript, votre salaire de base ne constitue qu’une partie de votre rémunération totale et est déterminé en fonction d’une échelle. Nos échelles salariales sont calculées selon les valeurs de référence locales en matière de coût de la main-d’œuvre propre à chaque poste, chaque niveau de poste et chaque emplacement géographique.
C’est une fierté d’être un employeur favorable à l’égalité professionnelle. En tant qu’entreprise centrée sur les personnes, BioScript croit foncièrement à l’importance de favoriser une culture accueillante exempte de discrimination, et de fournir un lieu de travail sain et sûr où l’ensemble des membres de l’équipe peuvent exprimer leur individualité. Grâce à notre engagement à la diversité, l’inclusion, l’appartenance et l’équité, nous sommes déterminés à fournir un milieu de travail où chaque personne se sent appréciée, respectée et soutenue chaque jour.
Nous nous engageons à créer un environnement inclusif et respectueux dans l’ensemble du Canada. Conformément aux lois provinciales applicables, y compris la Charte de la langue française du Québec, l’affichage du présent poste est publié en français et en anglais, le cas échéant. Pour les postes au Québec, la maîtrise du français est nécessaire afin d’effectuer les tâches quotidiennes.
Nous encourageons et acceptons toutes les candidatures; toutefois, nous communiquerons seulement avec les personnes dont la candidature a été retenue pour une entrevue. Des mesures d’adaptation sont offertes sur demande aux candidates et candidats qui participent à tous les aspects du processus de sélection. Si vous avez des demandes, veuillez envoyer un courriel à l’équipe d’attraction de talents à View email address on jobs.jobcopilot.com .
Laissez votre marque! Si transformer vos idées en résultats extraordinaires vous passionne, et si vous joindre à une équipe tournée vers l’avenir vous réjouit, nous aimerions recevoir votre candidature!
#INDA
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