Quality Assurance Specialist
4 weeks ago
Posting closing date: June 19th, 2024
Date de fin d’affichage : le 19 juin, 2024
Status: Temporary, Full-Time (12 months)
Statut : Temporaire, temps plein (12 mois)
(Français ci-dessous)
Quality Assurance Specialist
Summary:
The Quality Assurance Specialist is responsible for disposition of the API and API intermediates, including the review of completed batch production and laboratory control records of critical process steps before disposition and ensuring that deviations are investigated and resolved.
Responsibilities:
Acts as a lead investigator Reviews production batch records Performs quality and compliance related activities as assigned Tracks and trends data for annual product review, water trend reports, and metrics. Authors and/or coordinates the completion of assigned reports. Provides final review and approval of CAPA, laboratory investigations and GMP procedures, protocols, forms and instructions; ensuring compliance to cGMPs, regulatory filings, and Pfizer policies/procedures. Performs or assists with audits and participates in inspection readiness plans and activities Administrating the document management and change control processes Maintaining a stability program to support retest or expiry dates and storage conditions Identifies and reports adverse events and product complaints as per Corporate procedure, including Your Reporting Responsibilities (YRR) training.The ideal candidate possesses the following qualifications:
Post-Secondary Education (Degree/Diploma) or relevant Quality experience; Knowledge of Quality Systems and cGMP in a pharmaceutical setting; Must have very good inter-personal skills, ability to prioritize and meet deadlines; Must learn quickly, be intuitive and self-reliant; Must have effective oral and written communication skills and be able to process procedure and form revisions; Computer skills – MS Office (Word, Excel, Power Point).We are proud to offer employees a flexible working model that is grounded on empowering colleagues to design their workdays so that they can maximize their productivity, enhance their work-life balance and support a way of working that fosters innovation and patient-centricity. Currently, our employees are expected to be on-site 2.5 - 3 days per week blending on-site collaboration and connection with off-site remote working when it makes business sense to do so.
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Spécialiste de l’assurance de la qualité
Description :
Le titulaire du poste est responsable de la disposition des ingrédients pharmaceutiques actifs (IPA) et des produits intermédiaires, ce qui inclut la revue des registres de fabrication complétés et des dossiers de contrôle de laboratoire des étapes critiques avant la disposition et de s’assurer que les déviations sont enquêtées et résolues.
Fonctions :
Agit comme investigateur principal. Passe en revue les registres de fabrication. Effectue les activités liées à la conformité et à la qualité qui lui sont assignées. Effectue le suivi des données en vue de l’examen annuel des produits et en prévision des rapports sur les tendances de la qualité de l’eau. Assure ou coordonne la rédaction des rapports qui lui sont confiés. Fait la révision finale et approuve les mesures correctives ou préventives, les analyses de laboratoire et les procédures soumises aux Bonnes pratiques de fabrication, de même que les protocoles, les formulaires et les directives; voit à la conformité pour tout ce qui a trait aux Bonnes pratiques de fabrication en vigueur, aux demandes faites aux organismes de réglementation et aux politiques/marches à suivre de Pfizer. Prend part ou collabore aux vérifications et participe activement aux activités et aux plans qui assurent une bonne préparation en vue d’une inspection. Administre les processus de gestion des documents et de contrôle des changements. Maintien le programme de stabilité pour soutenir les retest ou dates d’expiration et les conditions de stockage. Veiller à la reconnaissance et à la déclaration des manifestations indésirables et des plaintes relatives aux produits, conformément aux normes de l’entreprise, dont la formation intitulée Responsabilités en matière de pharmacovigilance.Le candidat idéal possède les qualifications suivantes :
Études postsecondaires (titre ou diplôme) ou expérience pertinente en assurance de la qualité; Connaissance des systèmes qualité et des Bonnes pratiques de fabrication en vigueur dans une entreprise pharmaceutique; Aptitudes démontrées en communications interpersonnelles, capacité d’établir des priorités et de respecter les délais impartis; Très bonne capacité d’apprentissage, raisonnement intuitif, confiance en soi; Aptitudes en communication orale et écrite ainsi que pourla révision des procédures et formulaires; Compétences en informatique – MS Office (Word, Excel, PowerPoint).Nous sommes fiers d’offrir à nos employés un modèle de travail flexible qui leur permet de planifier leurs journées afin de maximiser leur productivité, d’atteindre un meilleur équilibre entre leur vie personnelle et leur vie professionnelle et de favoriser une nouvelle façon de travailler, qui sera centrée sur les patients et stimulera l’innovation. Actuellement, nos employés sont tenus de travailler sur place 2.5 à 3 jours par semaine, en combinant la collaboration et la communication en présentiel et le télétravail, lorsque cela est approprié pour l’entreprise.
At Pfizer, we embrace diversity and inclusion for innovation and growth. We are committed to building inclusive teams and an equitable workplace for our employees to bring their true selves to work.
We also strive to provide an accessible candidate experience for our prospective employees with different abilities. Please let us know if you need any accommodations during the recruitment process.
Chez Pfizer, nous accueillons la diversité et l'inclusion pour stimuler l'innovation et la croissance. Nous sommes déterminés à créer des équipes inclusives et un milieu de travail équitable pour que nos employés puissent exprimer leur vraie personnalité au travail.
Nous nous efforçons également d'offrir une expérience de candidature accessible à nos employés potentiels ayant des habiletés différentes. N'hésitez pas à nous faire savoir si vous avez besoin de mesures d’adaptation au cours du processus de recrutement.
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