Johnson & Johnson Careers
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Delegate QP Vaccines
Requisition ID: 1700213886W
• Serves as the Quality Point of Contact and Delegate IMP QP for Vaccines.
• Acts as IMP QP representative for new Vaccine Introductions, including, but not limited to, timely availability of Quality Agreements.
• Serves as champion for IMP QP requirements during development of new vaccine products, including fit-for-purpose strategies on GMP requirements. Applies Quality Risk Management tools in support of smart development.
• Ensures Quality and Compliance operational targets are met.
• Reviews and approves related GMP documents such as procedures and work instructions, investigations, etc.
• Supports and acts as spokesperson during Health Authority inspections and customer audits.
• Remains current in knowledge, skills and industry trends.
• With focus on Quality activities, develops and fosters an environment of innovative thinking through e.g. benchmarking, training, participation in industry forums.
• Reports Quality trends and makes a positive contribution by making suggestions for improvement.
• University degree, scientific orientation (pharmaceutical, chemical or biological sciences). Industrial Pharmacist (Qualified Person) is a must.
• At least 5 years experience in pharmaceutical industry.
• Mobility is important, since regular presence at the Leiden facility is expected. • Demonstrated ability to work independently while staying connected with key stakeholders.
• Experience in Large Molecule development and production, more specifically with vaccines.
• Ability to quickly assimilate new technologies, perform risk assessment and develop action plans. • In-depth knowledge in cGMP (domestic & international), ICH guidelines, policies, standards and procedures.
• Experience with Quality Systems.
• Experience with regulatory inspections and preparedness.
• Demonstrated ability to work across organizational boundaries through influencing, negotiation and partnering. Negotiation, communication and presentation skills across all levels are important.
• Understands the business implications regarding quality positions and decisions.
Janssen Pharmaceutica N.V. (7555)