Responsible Person
Il y a 3 mois
Job Description
General position summary:
The Responsible Person (Senior Manager), GDP Operations Quality, Benelux Role is responsible for ensuring the quality system is in place meeting the requirements of GDP and act as both Responsible Person (RP) on the Wholesale Distribution Authorisation (WDA) of Vertex Pharmaceuticals (Belgium) and Vertex Pharmaceuticals (Netherlands). Responsible Person Benelux role works with International QA Management team supporting continuous improvement initiatives and projects. In addition, this role helps to establish an appropriate QMS to support any aspects of the GMPs required for supply of ATMP in Benelux and acts as the commercial quality contact ensuring local compliance to the MAH and GMP requirements.
This Position Reports to: Associate Director, GDP Operational Quality
Key Responsibilities:
- Build strong working relationships with International Supply Chain, Regulatory, Technical Operations and the Global quality functions.
- Work cross-functionally with all levels to foster exceptional collaboration.
- In cooperation with International QA team, establishes and maintains corporate quality objectives, actively promotes an effective quality management system (QMS) in Belgium and the Netherlands.
- Effectively fulfils the role requirements of the Responsible Person for Vertex Pharmaceuticals (Belgium) and Vertex Pharmaceuticals (Netherlands)
- Responsible for maintaining the Warehouse and Distribution Authorization
- Perform RP duties as per GDP guidelines by; ensuring that a quality management system is implemented and maintained; focusing on the management of authorised activities and the accuracy and quality of records; ensuring that initial and continuous training programmes are implemented and maintained; coordinating and promptly performing any recall operations for medicinal products; ensuring that relevant customer complaints are dealt with effectively; ensuring that suppliers and customers are approved; approving any subcontracted activities which may impact on GDP; ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary corrective measures are put in place; keeping appropriate records of any delegated duties; performing the ‘administrative release’ of batches to the Belgian market in compliance with the local regulations deciding on the final disposition of returned, rejected, recalled, or falsified products; approving any returns to saleable stock; ensuring that any additional requirements imposed on certain products by national law are adhered to; Supervision and management of (product quality) complaints in compliance with procedures and local regulations as well as supervision of logistic complaints; Act as first point of contact towards the competent authorities in quality related matters, including suspected falsified medicinal products Be involved in any decision to quarantine or dispose recalled or falsified products and authorize the disposition of returned medicinal products; Prepare and guide GDP inspections or audits Supervision/management of both self-inspections and external audit programs Ensure permanent availability to the health authorities; in case of absence, delegate his/her duties and keep appropriate records relating to any delegation.
- Provide QA oversight of all GDP activities in accordance with local requirements; ensure product procurement, storage and distribution are managed in accordance with GDP requirements.
- Build effective relationships with 3PL QA in order to manage issue resolution, process improvements, returns handling, KPI reporting and ensuring overall quality oversight.
- In cooperation with supply chain, ensure that Vertex Pharmaceuticals (Europe) Limited supply chain maps are maintained for all distribution channels, including export countries.
- Proactively partner with other commercial departments to ensure quality aspects of new launches are properly handled. Set up effective collaborations with functional areas such as Regulatory, Supply Chain, local country manager.
- Lead local affiliate Management Reviews.
- Provide guidance and monitor quality issues related to products and GDP to resolution within the company and with external parties including escalation to senior management where applicable.
- Raise and review documentation including change controls, deviations, CAPAs, SOPs and specifications relating to distribution activities. Provide training if required.
- Maintain, review, and update Standard Operating Procedures for Quality Assurance and Distribution related activities ensuring compliance with GDP regulations.
- Ensure Quality Technical Agreements are in place for all outsourced activities.
- Ensure supplier audits are performed as per scheduled frequency, participating as lead auditor/audit team member, where required.
- Contribute to defining standard GDP quality KPIs and to review quality indicators with recommendatio
-
Responsible Continuous Improvement
Il y a 3 mois
Brussels, Belgique SNCB Temps pleinComment pouvez-vous faire la différence ?- Le Responsible Continuous Improvement (CI) initie et gère des projets et des actions dans les trois domaines d'amélioration continue des ateliers : pratiques opérationnelles, systèmes de management, attitudes et comportements du personnel.- Votre rôle consiste à aider les ateliers à améliorer leur...
-
Commercial Quality Assurance Manager
Il y a 3 mois
Brussels, Belgique Grünenthal Temps plein**Country**:Belgium**City**:Brussels**Department**:Global Operations & Production**Job ID**:43890- Our people in - **Manufacturing & Global Operations** share two priorities: getting things done and making things better. If you’re a dynamic person with a positive mindset, you’ll fit in well here. It’s an international team with a powerful spirit of...
-
Responsible Continuous Improvement
il y a 2 semaines
Brussels, Belgique SNCB Temps pleinComment pouvez-vous faire la différence ?- Le Responsable Amélioration Continue (CI) initie et gère des projets et des actions dans les trois domaines d'amélioration continue des ateliers : pratiques opérationnelles, systèmes de management, attitudes et comportements du personnel.- Votre rôle consiste à aider les ateliers à améliorer leur...
-
Responsible Continuous Improvement Brussels
Il y a 2 mois
Brussels, Belgique NMBSSNCB Temps pleinComment pouvez-vous faire la différence ? Le Responsable Amélioration Continue (CI) initie et gère des projets et des actions dans les trois domaines d'amélioration continue des ateliers : pratiques opérationnelles, systèmes de management, attitudes et comportements du personnel. Votre rôle consiste à aider les ateliers à améliorer leur...
-
Product Quality Representative Benelux
il y a 1 semaine
Brussels, Belgique Lilly Temps pleinAt Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities...
-
General Manager
Il y a 3 mois
Brussels, Belgique Nestia Hospitality Group Temps plein**JOB DESCRIPTION** **Function’s Description**: As Hotel Manager, you are a true entrepreneur. You are responsible for making the hotel known in the region. You develop sales and manage the results. You are responsible for your profit and loss account, the staff and the satisfaction of the guests. You are responsible for overseeing day-to-day business...
-
Commercial Officer Real Estate
Il y a 3 mois
Brussels, Belgique Intelect Temps pleinAre you commercially minded and looking for a position in the real estate world? Do you like working in an international environment and do English and French or Dutch have no secrets for you? Then this is the job for you! For one of our clients in the Brussels region, we are looking for a commercial employee within the rental of apartments. You will be...
-
Freelance Payroll Specialist
Il y a 3 mois
Brussels, Belgique Balance HR Temps plein**ORGANIZATION**: - Pharmaceutical sector - Growing environment **YOUR ROLE**: - You are responsible for the administration and onboarding new hires, ensuring adherence to established processes. - You inform relevant parties for the procurement of vehicles, fuel cards, IT equipment, mobile phones, etc. - You manage the HR Database using the appropriate...
-
Senior Legal Advisor
Il y a 3 mois
Brussels, Belgique Strand Associates Consulting Temps pleinWhat you'll do - You are responsible for the legal aspects in the fields of M&A transactions (incorporation of companies, acquisitions, mergers, joint ventures, etc.), corporate governance and corporate sustainability. You also deal with questions about company law and competition law. - You are responsible for the organization of the general shareholders'...
-
Expert Consultant Medical Life Acceptance
Il y a 3 mois
Brussels, Belgique EVERTYS Temps plein**Expert consultant Medical life acceptance****: Our client, a renowned company active in the insurance sector based in the center of Brussels, is looking for an Expert consultant Medical life acceptance to strengthen their departement of Broker Life Operations - Region- Brussels- Contract type- Project Consultant**_Hi, I'm Bruno and I would like to help you...
-
Claims Handler Construction
Il y a 3 mois
Brussels, Belgique Axis Temps pleinWe are looking for a Senior claims administrator to join our client's team. As a construction industry insurer, you will be responsible for managing complex claims BA Construction from A to Z. Are you the person we are looking for? Feel free to read on & contact us today! **Description** - As such, you will be primarily responsible for the complete...
-
Accounting Manager
Il y a 4 mois
Brussels, Belgique Robert Half Belgium Temps plein**Robert Half Interim Management** is currently looking for an **Accounting Manager ad interim** (M/F/x) for a 6 months assignment. **Robert Half Interim Management** is currently looking for an **Accounting Manager ad interim** (M/F/x) for a 6 months assignment. Our client is located in Brussels region. As **Accounting Manager ad interim** you will be...
-
General Manager
Il y a 3 mois
Brussels, Belgique Radisson Liège City Centre Temps plein**JOB DESCRIPTION** **Resume**: The Radisson Liège City Centre Hôtel is looking for an entrepreneurial General Manager. **Function’s Description**: As Hotel Manager, you are a true entrepreneur. You are responsible for making the hotel known in the region. You develop sales and manage the results. You are responsible for your profit and loss account,...
-
Bulk & Onsite Business Controller
Il y a 3 mois
Brussels, Belgique Air Liquide Temps plein**French** L'activité Industrial Merchant d'Air Liquide sert plus de 2 millions de clients industriels dans le monde, de l'artisan à la grande entreprise, dans des secteurs aussi divers que l'agroalimentaire, la sidérurgie, l'énergie, la chimie, l'automobile, la construction et l'aéronautique. Le Groupe propose des solutions complètes et innovantes en...
-
Call Agent
Il y a 3 mois
Brussels, Belgique HALFIN ELECTRONICS Temps pleinThe database profiling student makes call and updates information on the companies in our system. After training, you will be responsible for updating (checking information) and developing (enriching data) the company files and contacts in the database. Who are we looking for? Your role: - Make data profiling calls to validate contact details. - Updating...
-
Restaurant Director
Il y a 3 mois
Brussels, Belgique Quality Seekers Temps plein**Company**: Atmospheric, contemporary, excellent vibe, professional guest service,... These are just a few key words that characterize the F&B service at this hotel. Although the hotel is part of a well-known international chain, it reacts flexibly and autonomously to contemporary food trends. That is why both business and leisure guests find their way to...
-
Freelance International Mobility and Benefits
Il y a 3 mois
Brussels, Belgique Balance HR Temps plein**ORGANIZATION**: - Energy sector - Growing environment **YOUR ROLE**: - You play an active role in optimizing our international mobility policy - You help establish benchmarks and formulate proposals based on an analysis of those benchmarks - You keep international mobility processes and procedures up to date - You be responsible for the smooth running...
-
Developer
Il y a 3 mois
Brussels, Belgique HNM Solutions Temps plein**Role: Golang Developer** **Location: Brussels, Belgium** **Language: English** **Description**: **What You’ll Be Responsible For** Building, testing, deploying, maintaining, and scaling backend services in a microservices architecture using the Go programming language, datastores, asynchronous processing using events, and more. Working with your...
-
Receptionist & Internal Relationship Manager Daily
Il y a 4 mois
Brussels, Belgique TRIODOS Belgium Temps plein**Function**: As the Daily Banking Receptionist and Relationship Manager, you will be working in a team of 7 colleagues who are responsible for managing all incoming and outgoing customer contacts as part of their business relations management. The Practice Leader shares the different operational objectives on a daily basis and tries to offer each Daily...
-
Truck Driver
Il y a 3 mois
Brussels, Belgique Isospray2.0 Temps pleinENG: We are seeking a versatile and motivated driver to join our team as a driver who will also actively participate in insulation works on construction sites. In this role, you will be responsible for driving our truck to transport equipment and materials to construction sites while actively assisting with insulation works. Key Responsibilities: Safe...
