Associe(e) principal(e) en qualite, Marque privee/ Senior Quality Associate, Private Label (contrat 18 Mois)

McKesson is an impact-driven, Fortune 10 company that touches virtually every aspect of healthcare. We are known for delivering insights, products, and services that make quality care more accessible and affordable. Here, we focus on the health, happiness, and well-being of you and those we serve we care.

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 tomorrows health today, we want to hear from you.

Relevant au Chef principale Qualite, Marque privee, lAssocie(e) principal(e), Qualite Marque privee est responsable de soutenir divers processus tels que la relache de produits, le lancement de nouveaux produits, ainsi que dautres activites connexes.

Ce role joue un role cle dans le maintien de lintegrite des operations de marques privees de McKesson, notamment en contribuant a la revue de la documentation des lots, a la gestion des activites de controle des changements et au soutien des analyses confirmatoires. De plus, le poste contribue aux initiatives damelioration continue et collabore avec les equipes internes ainsi quavec les partenaires externes afin datteindre et de maintenir les objectifs qualite.

• Enregistrer la documentation de lots recue dans le systeme de gestion de la qualite et faire la pre-revue.

• Recevoir et examiner la documentation de lots afin dassurer la conformite aux exigences reglementaires et internes de qualite produit, incluant notamment :

  • Certificat danalyse

  • Certificat de conformite (fabrication et conditionnement)

  • Deviations et enquetes

• Participer au processus de controle des changements pour les relaches, incluant linitiation de DCR et les taches associees.

• Soutenir les processus de tests confirmatoires (creation des demandes danalyse, suivi des resultats).

• Collaborer aux revues completes de dossier des lots lorsque requis.

• Creer, evaluer et mettre a jour les documents lies aux DMF dans le systeme de gestion de la qualite.

• Soutenir le processus de lancement de nouveaux produits au besoin.

• Soutenir les demandes APQR et de stabilite aupres des fournisseurs et assurer les suivis selon le calendrier.

• Rediger, formater, reviser, traduire et mettre a jour les SOPs, instructions de travail, formulaires et documents controles.

• Gerer la documentation dans MasterControl (standardisation des gabarits, controle documentaire, archivage).

• Collaborer avec les partenaires et fabricants pour aligner les priorites.

  • Animer les reunions fournisseurs

  • Preparer les ordres du jour

  • Documenter les comptes rendus

• Soutenir les activites liees a la liberation.

• Contribuer a la preparation des inspections de Sante Canada et corporatives; diriger ou soutenir des projets speciaux au besoin.

• Participer aux audits internes et externes.

• Contribuer aux initiatives damelioration continue.

• Effectuer toute autre tache connexe.

Responsabilites generales

• Assurer la conformite aux exigences de formation GMP.

• Travailler avec un encadrement modere dans son domaine dexpertise.

• Recevoir occasionnellement des directives sur des aspects qualite specifiques et suivre les procedures etablies.

• Fournir du support aux projets et mandats au besoin.

• Contribuer aux initiatives damelioration continue.

• Collaborer efficacement avec les equipes internes et partenaires externes.

Exigences cles du poste

Formation

• Baccalaureat en sciences de la sante, ou experience equivalente

• Minimum de 3 ans dexperience en pharma/operations/fabrication

• Bonne connaissance des lignes directrices pertinentes.

Competences techniques et comportementales

• Bilingue (francais et anglais, oral et ecrit)

• Excellentes competences en communication

• Experience avec un systeme electronique de gestion de la qualite

• Maitrise de la suite Microsoft (Outlook, Word, Excel, PowerPoint).

Competences en gestion / aptitudes

• Rigueur et souci du detail

• Capacite a travailler sous pression

• Excellentes competences interpersonnelles et redactionnelles

• Forte capacite dorganisation et gestion du temps (multiprojets)

• Esprit dequipe et collaboration

• Capacite a coordonner des activites transversales

• Engagement envers lamelioration continue.

Le/la titulaire de ce poste aura a soutenir de facon quotidienne des clients internes et/ou externes a lexterieur du Quebec et/ou aux Etats-Unis. Par consequent, ce poste requiert une maitrise de langlais a lecrit et a loral. Veuillez noter que le nombre de postes dont les taches requierent une connaissance de la langue anglaise a ete restreint dans la mesure du possible.

***********************************************************************

Reporting to the Senior Quality Manager, Private Label, the Senior Quality Associate, Private Label, will be responsible for supporting various processes such as Release, New Product Launch and others.

The Senior Quality Associate will play an important role in supporting the integrity of McKessons private label operations by contributing to batch documentation review, managing change control activities, and supporting confirmatory testing. Additionally, the position contributes to continuous improvement initiatives and collaborates with internal teams and external partners to achieve and maintain quality objectives.

Specific Responsibilities

• Record received batch documentation in the Quality Management System (QMS) and perform the initial review.

• Receive and review batch documentation to ensure compliance with regulatory and internal product quality requirements, including but not limited to:

  • Certificates of Analysis

  • Certificates of Compliance (manufacturing and packaging)

  • Deviations and investigations

• Participate in the change control process for batch releases, including the initiation of DCRs and associated tasks.

• Support confirmatory testing processes (creation of analysis requests and followup on results).

• Collaborate on full batch record reviews as required.

• Create, review, and update Drug Master File (DMF)related documents within the Quality Management System.

• Support new product launch activities as needed.

• Support APQR and stability requests with suppliers and ensure followup in accordance with established timelines.

• Draft, format, review, translate, and update SOPs, work instructions, forms, and controlled documents.

• Manage documentation in MasterControl (template standardization, document control, and archiving).

• Collaborate with partners and manufacturers to align priorities.

• Facilitate supplier meetings, including:

  • Preparing agendas

  • Documenting meeting minutes

• Support activities related to batch release.

• Contribute to the preparation of Health Canada and corporate inspections; lead or support special projects as required.

• Participate in internal and external audits.

• Contribute to continuous improvement initiatives.

• Perform any other related duties.

• Ensure compliance with GMP training requirements.

• Work with moderate supervision within area of expertise.

• Receive occasional guidance on specific quality matters and follow established procedures.

• Provide support to projects and assignments as needed.

• Contribute to continuous improvement initiatives.

• Collaborate effectively with internal teams and external partners.

Education

• Bachelors degree in Health Sciences or equivalent experience.

• Minimum of 3 years of experience in pharmaceutical, operations, or manufacturing environments.

• Strong knowledge of applicable regulatory guidelines.

Technical and Behavioral Skills

• Bilingual (French and English), both written and spoken.

• Excellent communication skills.

• Experience with an electronic Quality Management System (eQMS).

• Proficiency in Microsoft Office (Outlook, Word, Excel, PowerPoint).

Management / Professional Competencies

• Strong attention to detail and rigor.

• Ability to work under pressure.

• Excellent interpersonal and written communication skills.

• Strong organizational and timemanagement skills (ability to manage multiple projects).

• Teamoriented with a collaborative mindset.

• Ability to coordinate crossfunctional activities.

• Commitment to continuous improvement.

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.

#LI-JT2

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

McKesson has become aware of online recruiting-related scams in which individuals who are not affiliated with or authorized by McKesson are using McKessons (or affiliated entities, like CoverMyMeds or RxCrossroads) name in fraudulent emails, job postings or social media messages. In light of these scams, please bear the following in mind:

McKesson Talent Advisors will never solicit money or credit card information in connection with a McKesson job application.

McKesson Talent Advisors do not communicate with candidates via online chatrooms or using email accounts such as Gmail or Hotmail. Note that McKesson does rely on a virtual assistant (Gia) for certain recruiting-related communications with candidates.

McKesson job postings are posted on our career site: careers.mckesson.com .

McKesson is an Equal Opportunity Employer

McKesson provides equal employment opportunities to applicants and employees, without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, age, genetic information, or any other legally protected category. For additional information on McKessons full Equal Employment Opportunity policies, visit our Equal Employment Opportunity page.

McKesson is committed to being an Equal Employment Opportunity Employer and offers opportunities to all job seekers including job seekers with disabilities. If you need a reasonable accommodation to assist with your job search or application for employment, please contact us by sending an email to (United States) Disability_Accommodation@McKesson.com or (Canada) Accessibility@mckesson.ca . Resumes or CVs submitted to this email box will not be accepted.

Join us at McKesson!