- Participer à la surveillance environnementale dans les zones de traitement de la fabrication en mettant l'accent sur les systèmes d'eau ;
- Suivre les procédures de prélèvement et de traitement des échantillons de surveillance environnementale tels que les échantillons de surveillance environnementale viables, non viables, de surface, de personnel, d'eau et de gaz selon les cédules ;
- Préparer les fournitures nécessaires à la surveillance environnementale et tenir à jour l'inventaire des fournitures ;
- Soutenir et interagir étroitement avec le personnel de fabrication et de qualité en termes de tous les aspects liés à la surveillance environnementale ;
- Suivre les BPF et les pratiques de sécurité du département ;
- Assister à diverses tâches du département ;
- Bonne connaissance des BPF de Santé Canada et de la FDA ;
- Démontrer la connaissance des techniques aseptiques appropriées ;
- Faire preuve de responsabilité et d'imputabilité dans un environnement d'équipe ;
- Solides compétences en informatique; compétences en communication et en relations interpersonnelles;
- Soucieux des détails ;
- Doit être flexible avec les heures de travail.
- Études: Minimum 2 années validées dans un programme d'études collégiales en sciences (minimum 30 crédits), et dans un programme en sciences biopharmaceutiques ou un domaine connexe est souhaitable ;
- Capacité de soulever ou de pousser jusqu'à 25 livres ;
- Capacité de rester debout et/ou assis pendant de longues périodes - jusqu'à quatre (4) heures à la fois ;
- Capacité de s'habiller et d'entrer dans un environnement aseptique / salle blanche ;
- Dextérité manuelle pour effectuer des fonctions de type clérical telles que taper, l'utilisation d'une souris, la copie, la télécopie, etc ;
- Possibilité de travailler sur un ordinateur et de visionner un écran à moins de 18 " du visage pendant de longues périodes - jusqu'à quatre (4) heures à la fois;
- Capacité de lire et de réviser des documents pendant de longues périodes - jusqu'à quatre (4) heures à la fois ;
- Bonnes compétences en communication orale et écrite et bonnes compétences interpersonnelles ;
- Bilingue en français et en anglais est préféré. (la maîtrise de l'anglais est requise pour assurer les échanges de documentations et communications avec d'autres sites de Grifols hors Québec et hors Canada (Espagne, USA).
- Perform sampling in the manufacturing processing areas including environmental monitoring and water systems.
- Follow procedures to collect and process environmental monitoring samples such as viable, non-viable, surface, personnel, water and gases as scheduled.
- Prepare supplies required for environmental monitoring and maintain inventory of supplies.
- Support and closely interact with manufacturing and quality personnel in terms of all aspects relating to environmental monitoring.
- Follow cGMP and department safety practices.
- Assist with various department tasks.
- Knowledge of Health Canada and US FDA cGMP's
- Demonstrate knowledge of proper aseptic techniques.
- Communicate effectively and promptly, escalate any issues that require management decisions
- Demonstrate high levels of values and integrity
- Demonstrate responsibility and accountability in a team environment.
- Strong computer skills; communication and interpersonal skills.
- Detail oriented.
- Must be flexible with working hours.
- Education: Minimum of 2 years validated in a Science College Program (min 30 credits), and in a Biopharmaceutical Sciences Program or related field preferred.
- Ability to lift or push up to 25 pounds.
- Ability to stand and/or sit for extended periods - up to four (4) hours at a time.
- Ability to gown and enter into an aseptic/clean room environment.
- Manual dexterity to perform clerical type functions such as typing, using a mouse, copying, faxing, etc.
- Ability to work at a computer and view video display terminal less than 18" away from face for extended periods - up to four (4) hours at a time.
- Ability to read and review documents for extended periods - up to four (4) hours at a time.
- Good oral and written communication skills and good interpersonal skills
- Bilingual in both French and English preferred (la maîtrise de l'anglais est requise pour assurer les échanges de documentations et communications avec d'autres sites de Grifols hors Québec et hors Canada (Espagne, USA).
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Stagiaire - Associé aux opérations d'Assurance Qualité - QA Operations Associate Intern - Montreal, Canada - GRIFOLS, S.A.
Description
Stagiaire - Associé aux opérations d'Assurance Qualité - QA Operations Associate Intern
Aimeriez-vous vous joindre à une équipe internationale qui oeuvre à améliorer le futur des soins de santé ? Voulez-vous améliorer la vie de millions de personnes ? Depuis sa fondation à Barcelone en 1909, Grifols est une société d'envergure mondiale de soins de santé qui s'efforce d'améliorer la santé et le bien-être des populations du monde entier. Nos quatre (4) divisions - Bioscience, Diagnostique, Hôpitaux et Produits biologiques développent, produisent et commercialisent des médicaments innovants, des solutions et des services dans plus de 100 pays et régions.
Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.
Titre du poste: Stagiaire - Associé aux opérations d'Assurance Qualité
Relève de: Gestionnaire Assurance Qualité
Résumé du poste
Le Stagiaire - Associé aux opérations d'AQ participe à la surveillance de l'environnement (EM) dans les zones de la fabrication en mettant l'accent sur les systèmes d'eau. Interagir étroitement avec le personnel de fabrication et de qualité et le soutenir en termes de surveillance environnementale.
Principales tâches et responsabilités
Reports to: QA Manager
Position Summary
The QA Operation Associate Intern participates in environmental monitoring in the manufacturing processing areas with an emphasis on water systems. Will closely interact with and support manufacturing and quality personnel in terms of environmental monitoring.
Key Duties and Responsibilities
Learn more about Grifols #J-18808-Ljbffr
