Johnson & Johnson Careers
Pharmaceutical Quality Officer Benelux
Requisition ID: 1805640532W
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found. The Local Operating Company ensures that these innovative medical solutions are launched into the Benelux market in the most optimal way to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The Job in General:
Janssen Cilag NV/BV, the Local Operating Company within the Benelux region, is recruiting for a (Senior) Pharmaceutical Quality Officer Benelux/RP.
The Pharmaceutical Quality Officer is part of the Business Quality Department Benelux. He/she plays an important role in the implementation and maintenance of Quality Systems, holds ownership of those systems and contributes to the continuous improvement of the Pharmaceutical Quality aspects of our business.
As a registered Responsible Person (RP) the Pharmaceutical Quality Officer Benelux jointly holds the responsibility to ensure GDP compliance in parallel with the Head of Quality Benelux and will act as a permanent back-up of the Head of Quality Benelux in this role.
Tasks and responsibilities:
· Act as local process owner for event and deviation management, CAPA management and change management systems
· Act as back-up for the Head of Quality, focussing on product quality complaint handling and product issue handling, recalls and field actions
- Assist in GxP inspections and audit preparation and provide support during actual inspection /audit execution
- Implement and lead the quality management review process enabling the company to identify opportunities for, and guarantee continual improvement of various compliance areas (GDP, GMP, RA, PV).
- Ensuring that new / revised quality management systems are implemented and maintained
· Guide the local Product Quality Review process, assuring compliance with the EU GMP guidelines and J&J Business Quality requirements
· Ensuring the execution of the JC GxP training program to support company objectives, both internally and externally towards vendors.
· Together with QA associate QMS, take leadership in document management processes.
· Act as primary contact for the European Distribution Center regarding batch version and batch status management
· Coordinating and performing promptly any recall operations
· Ensuring that relevant customer complaints are dealt with effectively
· Authorizing the return to saleable stock of any returned medicines
- Degree in Pharmacy /Chemistry/Medicine or a related scientific discipline.
- Preferably 2 years experience in pharmaceutical or related industry, ideally with a mix of manufacturing / Distribution / QA operations experience.
- Understanding of pharmaceutical product development, qualification, manufacturing, packaging, validation, testing, release and distribution processes and their relation to the marketing authorization process.
- Up-to-date knowledge of relevant pharmaceutical legislation, directives and guidelines, GMP/GDP and Janssen / J&J policies and SOP’s. Understanding of the evolutions and trends in the healthcare legislation in general are a plus
- Ability to work independently, systematically and orderly with great accurateness.
- Creative and pro-active team player.
- Strong analytical and problem-solving skills, able to solve new issues in a practical and creative manner.
- Excellent communication and collaboration skills, quick learner, able to work on multiple simultaneous tasks with limited supervision, positive with “making it happen” attitude.
- Thorough command of the Dutch, English and preferably French language.
Janssen-Cilag Netherlands (8345)