Senior Specialist Quality Systems
View: 161
Update day: 29-03-2024
Location: Schaffhausen Schaffhausen SH
Category: IT - Software
Industry: Medical Equipment Hospitals Health Care Pharmaceutical Manufacturing
Job type: Full-time
Job content
Caring for the world ... starting with the individual. This guiding principle inspires and unites the people at Johnson & Johnson. The culture of caring is at the heart of our corporate philosophy, which is anchored in the Credo.Cilag AG is an international manufacturing company of the pharmaceutical division of the Johnson & Johnson Group and produces pharmaceutical and medical device products as well as active pharmaceutical ingredients (APIs) for global markets at its production site in Schaffhausen. Thanks to our innovative products, processes and technologies, Cilag AG is today one of the leading pharmaceutical companies in Switzerland and at the same time a strategic launch and growth site and competence center for sterile production.
We Are Looking For a Highly Committed
Senior Specialist Quality Systems (f/m/d)
Responsibilities
- Act as a Subject Matter Expert/ Site Key User for Non-Conformance and CAPA systems, processes, procedures, and activities
- Provide end-user support for the site e.g. Training, System Access, ad-hoc support
- Host the site CAPA Review Board and collect related Metrics
- Act as an assigned Quality lead for the site to support Product Quality Reviews
- Interact and guide external Service Provider who is responsible for data collection and reporting of Product Quality Reviews
- Represent the site in global councils and shape the quality system environment
- Participation as Subject Matter Expert in Health Authority inspections and audits
- Innovate solutions to quality system gaps and lead continuous improvement projects in regards to standardization and simplification to drive compliance and/or efficiency.
- Establish Quality Data Dashboards to simplify data collection and enable visualization of metrics to support the site and drive Quality and compliance
- Support the development and introduction of new processes and procedures which may impact multiple functions or regions
- Independently handle and prioritize highly complex and diverse workload ensuring deliverables are timely, accurate, and meet their intended objective
- Bachelor or master’s degree in a science or technical field
- Proven experience in a GMP Environment
- Strong knowledge in Trackwise preferred
- Basic Tableau skills preferred
- Experience as project lead preferred
- Advanced skills in German and English (oral and written)
- Strong communication (verbal & written) and interpersonal skills, self-awareness and flexibility required.
- Proven ability to lead and influence others with very good communication and presentation skills.
- Experience and demonstrated skills in navigating in a matrix environment, handling complexity, collaborating across boundaries, and influencing without authority required.
Primärer Standort
Schweiz-Schaffhausen-Schaffhausen-
Organisation
Cilag AG (8562)
Funktion
Quality
Requisition ID
2105985600W
Deadline: 13-05-2024
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