Johnson & Johnson
Johnson & Johnson Worksense (via Randstad Sourceright) is responsible for finding, engaging and contracting talent for the Johnson & Johnson contingent workforce
Currently we are looking for a Quality Specialist for 6 to 8 months with possible extension
Hybrid working (3 days in Bern)
Aim of the position
- Ensuring that suppliers, systems and facilities are in state of sustainable compliance with GMP requirements
- Provide quality guidance to all departments on site for the different cGMP related subjects
- Support the execution of health and non-health authorities inspections
- Ensure supplier quality is always according to regulations and standards
- Contact person to EQ
- Contact person for production, development, and quality control for all quality related topics but especially on Supplier Quality topics
- Contact person for Change Notifications from Suppliers regarding Materials for Production.
- Ensure the quality of materials for production and supplier
- Develop and deploy KPIs and Metrics to support continuous improvement.
- Ensure that deliverables assigned to LMM as part of projects are successfully achieved on time
- Support review and release of batches of purchased raw materials and their qualification
- QC Oversight for review/approval of process documents and Method validation
- Support the GMP-compliant production of active ingredients and drugs for clinical trials and market launch
- Support Product MBR review
- Support review of executed batch records
- Support QA oversight for aseptic processing
- Review and approval of SOPs, work instructions and risk assessments
- LIMS profiles? approval for Materials for Productions § Support SAP Set up for Materials for Production
- Support Quality Operations and Product Quality in ensuring GMP readiness for NPI projects
- Support for internal and external audits as subject matter expert
- Support complaints management
- Support for risk management at the site
- Support the execution of external inspection and audits from local and foreign Health Authorities, including the FDA, and customers
- Support the response to reports from external inspection and audits
- Support the execution of audits from the corporate compliance including responding to the audit report
- Delivery on annual goals & objectives, guided by Our Credo and Leadership Imperatives
- Fulfilment of duties and tasks as described before and as to be defined in the yearly performance talks.
Education & Experience
- University degree in pharmacy, natural science, medicine, or equivalent
- Minimum 2 years of working experience in a GMP related environment, preferable in Quality
Skills & Competences
- Strong knowledge of GMP requirements for commercialized, development and clinical products
- Cultural sensitivity
- Good leadership capabilities § Good communication skills in German and English language
- Excellent communication and teamwork skills
- Ability to work in a diverse and changing environment
- Flexibility, accuracy and reliability
- Ability to prioritize and to continuously review priorities
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.If you are interested in hearing more about our Quality Specialist role, please do not hesitate to apply through the provided link today and a member of our recruitment team will be in touch!
That is why we in Switzerland we are working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feel that they belong and can reach their potential. No matter who they are.
Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”!