Description
GMP Specialist/Leiden, Netherlands/8 Months Contract/35 to 67 EUR (Per Hour)
GMP Specialist:
The department Quality Systems & Compliance is responsible for (the improvement of) the compliance status within Janssen Biologics B.V. The main focus areas are: Inspection readiness, Internal auditing, GMP training, Management review, CAPA management, Quality metrics, and Compliance gap assessments. We work closely together with the GMP departments within Janssen Biologics B.V. and associated companies worldwide.
GMP Specialists.
Activities and responsibilities:
- You are responsible for one or more focus areas within the department.
- You make sure the GMP Quality Processes adhere to the applicable GMP regulations (eg Eudralex, FDA, ICH).
- You make sure the GMP Quality Processes are consistent within the organization through internal audits, gap assessments, and risk assessments.
- You provide GMP advice to improvement projects and you have an active role in the implementation of such projects.
- You organize and support Health Authority inspections, 3rd party inspections, and Headquarters audits.
- You are Quality approver for improvements identified during inspections and audits.
- You make sure Performance, Quality, and Compliance reviews are generated.
Job requirements (education, experience, knowledge, skills)
- Master degree or equivalent in biosciences, pharmacy or equivalent.
- Pharmaceutical or related industry work experience, of which a substantial part in quality or compliance functions.
- Knowledge of GMP regulations and preferably knowledge of automated systems and/or validation.
- Proven leadership skills in a professional environment.
- Able to translate complex situations to simple, practical solutions.
- Able to influence people without formal authority.
- Keen to recognize opportunities for improvement in and outside the department.
- Preferably experience with Lean tools.
- Proactive, result oriented, and team player.
- Excellent communication and advisory skills both in English and Dutch.
The Company
Johnson & Johnson is an American multinational medical devices, pharmaceutical and consumer packaged goods manufacturer founded in 1886.
If you match these requirements, please apply in the normal way. Elevate will send you an email, please open, click and action that email and your application will be visible to the hiring organisation directly.