Publié il y a 14 jours
Documentation Specialist
@ GRIFOLS, S.A.
Mississauga, Ontario
En bref
Grifols, a global healthcare company, is hiring a Documentation Specialist to support the Quality Assurance department in controlling GMP documentation, filing, tracking and archiving. The role maintains the document control system, oversees change control, and monitors activities affecting plasma product quality and donor safety.
Responsabilités :
- Maintenir les modèles de documents GMP et les systèmes de suivi
- Superviser le processus de contrôle des changements
- Réviser les SOP selon les exigences canadiennes et cGMP
- Compiler les données de marqueurs viraux pour le rapport PPTA
Résumé des exigences :
- Baccalauréat en sciences de la santé
- Deux ans d'expérience en collecte de plasma ou industrie pharmaceutique
- Connaissance des systèmes de gestion de la qualité
- Compréhension des règlements GMP de Santé Canada, FDA et EMA
- Maîtrise de Microsoft Office
Outils et compétences
Source et dates
Site carrière / système de candidatures · successfactors
- Date publiée par l’employeur
- 2026-10-25
- Première détection par notre source
- 2026-10-26
- Mise à jour du dossier source
- 2026-10-31
Ces dates décrivent le dossier source, pas une vérification en direct du recrutement. Consultez l’offre originale.
Détails du poste
| Niveau | Débutant |
| Domaine | Assurance qualité |
| Expérience | 2 an(s) et plus |
| Déplacements | avion : aucun · route : aucun |
| Milieu de travail | Bureau, Entrepôt, Usine |
| Position | Surtout assis |
| Exigences physiques | physique faible · ordinateur élevé |
| Langues | English, French |
| Formation | Baccalauréat (exigé) |
| Domaines d’études | Health-related sciences |
Résumé et détails rédigés par l’IA à partir de l’offre; l’offre de l’employeur fait foi.
GRIFOLS, S.A.
Profil d’entreprise sauvegardé
Renseignements historiques provenant d’un profil The Jobs API sauvegardé (champs LinkedIn/Crunchbase). Ils ne sont pas vérifiés en temps réel; les chiffres peuvent avoir changé. Les valeurs manquantes restent inconnues.
Innovating for patients and society
Description complète de l’entreprise
Grifols is a global healthcare company founded in Barcelona in 1909 committed to improving the health and well-being of people all over the world. A leader in essential plasma-derived medicines and transfusion medicine, we develop, produce and provide innovative healthcare services and solutions in more than 110 countries. Patient needs and our ever-growing knowledge of many chronic, rare and prevalent diseases, sometimes life-threatening, drive our innovation in plasma-based therapies and other biopharmaceuticals to enhance quality of life. Grifols is focused on treating conditions across a broad range of therapeutic areas: immunology, hepatology and intensive care, pulmonology, hematology, neurology and infectious diseases. With a workforce of over 23,000 employees in more than 30 countries and regions, we are committed to a sustainable business model that sets the standard for continuous innovation, quality, safety and ethical leadership in the industry. Our work has a positive social and economic impact in the countries where we operate, creating jobs and generating wealth. People are at the heart of what we do, and we strive to create an inclusive, diverse, fair and equal society. Maintaining and promoting a workforce that reflects this reality leads to enhanced professional relationships and helps us to give our best to patients, donors and customers. In 2024, Grifols was named one of TIME’s ‘World’s Best Companies’ for the second year in a row, reaffirming our commitment to excellence. We were also recognized by Forbes as one of the "Best Employers for Women 2023," reflecting our dedication to fostering an inclusive and supportive workplace for all. To maintain a positive community and overall respectful communication, please keep our community guidelines in mind.
- Abonnés LinkedIn
- 286 595
- Personnes associées sur LinkedIn
- 13 691
- Bureaux déclarés
- Parc Empresarial Can Sant Joan, Av. de la Generalitat, 152-158, Sant Cugat del Vallès, Barcelona 08174, ES
- Carrer de Palou, 6, Parets del Valles, Catalonia 08150, ES
- Catégories d’activité
- Health Diagnostics
- Health Care
- Biopharma
- Clinical Trials
- Biotechnology
- Life Science
- Medical
- Manufacturing
- Pharmaceutical
- Autres noms enregistrés
- Grifols Egypt for Plasma Derivatives
- GRIFOLS, S.A.
- Grifols
- Spécialités
- Plasmapheresis
- Plasma derived therapies
- Diagnostics
- Intravenous therapies
- Clinical nutrition
- Automate drug compounding
- Drug inventory control
- and Healthcare
- Le profil indique une agence de recrutement
- Non
- Investissement total déclaré
- 0
La devise et la date d’observation ne sont pas fournies; ce n’est ni une valorisation actuelle ni une ronde de financement.
Grifols is a global healthcare company founded in Barcelona in 1909 committed to improving the health and well-being of people all over the world. A leader in essential plasma-derived medicines and transfusion medicine, we develop, produce and provide innovative healthcare services and solutions in more than 110 countries. Patient needs and our ever-growing knowledge of many chronic, rare and prevalent diseases…
| Champ | Valeur |
|---|---|
| Secteur | Pharmaceutical Manufacturing |
| Taille | 10,001+ employees |
| Siège social | Sant Cugat del Vallès, Barcelona |
| Type d’organisation | Public Company |
| Fondée en | 1909 |
| Spécialités | PlasmapheresisPlasma derived therapiesDiagnosticsIntravenous therapiesClinical nutritionAutomate drug compounding Drug inventory controland Healthcare |
| Offres sur Jobsy | 33 |
| Voir la page |
Souhaitez-vous rejoindre une équipe internationale qui travaille à l'amélioration des soins de santé ? Voulez-vous améliorer la vie de millions de personnes ? Grifols est une entreprise mondiale de soins de santé qui, depuis 1909, travaille à l'amélioration de la santé et du bien-être des personnes dans le monde entier. Nous sommes leaders dans le domaine des médicaments dérivés du plasma et de la médecine transfusionnelle et nous développons, produisons et commercialisons des médicaments, des solutions et des services innovants dans plus de 110 pays et régions. |
Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. |
Position title: Documentation Specialist
Reports to: Quality Management System Manager
Position Summary:
The Documentation Specialist provides support to the QA department in controlling GMP documentation processing, filing, tracking and archiving. The individual maintains various data bases for document tracking and maintains QA operations file.
Position Objective:
The Documentation Specialist is responsible for maintaining the document control system and monitoring, tracking, and recording all activities that directly or indirectly impact product quality, donor suitability, donor safety, plasma testing, and plasma warehouse operations. The role ensures that documentation processes are effectively managed and maintained in compliance with applicable quality and regulatory requirements.
The Documentation Specialist is also responsible for implementing appropriate controls to ensure the accuracy, integrity, availability, and legibility of all controlled documents, supporting the reliability of records and the overall effectiveness of the quality management system.
Position Responsibilities:
- Maintain GMP document templates and tracking systems such as but not limited to: SOPs, forms, protocols and reports.
- Oversee the change control process, including but not limited to: tracking and coordinating changes, circulating requests for approval, preparing documents, distribution of approved changes
- Other related duties/responsibilities as required or assigned by the Quality System Manager. To ensure proper implementation of document control systems in GEPD plasma supply chain areas.
- Review SOPs related to Documentation Lifecycle Systems, following the guidelines established according to Canadian regulations and the guidelines established according to cGMP requirements and Good Documentation Practices.
- Ensure compile of all the information related to Documentation Lifecycle referred to Key Process indicators established for the Quality system.
- To define a system of control of documentation that ensures that documents within the Quality Management System should be regularly reviewed and kept up to date.
- Compile and prepare Grifols viral marker data for PPTA reporting.
- Perform assigned tasks by direct manager.
Required Skills, Qualifications and Experience:
- Bachelor ‘s Degree in Health-related Sciences.
- Minimum two (2) years of Blood/plasma collection or pharmaceutical industry experience.
- Understanding of quality management systems and related regulations is required.
- Ability to understand, explain, follow, and enforce SOPs and protocols.
- Experience in change and deviation management preferred.
- Proficiency in Microsoft Office Suite (Word, Outlook, Excel).
- Understanding of Health Canada, FDA and EMA GMP regulations. Organized and able to manage time effectively.
- Ability to work within a highly regulated, labor intensive environment.
- Ability to understand, explain, follow, and enforce SOPs and protocols.
- Ability to plan, communicate and execute activities for the improvement of overall operations.
- Strong integrity and commitment to Quality and Compliance.
- Excellent oral and written communication skills to produce clear and concise factual findings and ability to present effectively to groups.
The salary range for this position is currently being assessed and will be disclosed upon completion of the compensation review process, in accordance with applicable transparency requirements.
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