We are currently looking for a Clinical Quality Systems Specialist who will be based in our Operational Headquarters in Zurich. The Clinical Quality Systems Specialist will be an integral part of the Clinical Quality Assurance (CQA) function, supporting the quality systems. The primary focus of this role is the management of SOPs within the electronic records management system. This position will also support the Learning Management System activities, assist with regulatory inspection readiness, inspection management and CAPA. Your tasks and responsibilities will include, but not be limited to the following:
- Maintain and support Clinical Quality SOP related Systems servicing Clinical Development and Biometrics, Medical Affairs, Regulatory Affairs and Drug Safety
- SOPs administration: review and approval workflow management, SOP editing , SOP lifecycle /ongoing review management
- Stakeholders / Author support and training
- Electronic Records management
- Process improvement
- Compliance check of SOP content against applicable regulations and related SOPs
- Support clinical quality training and related systems
- Provide support in regulatory inspections
- Monitor department CAPA execution to ensure accuracy and completeness
- Represent CQA in assigned projects and cross functional groups
- Keep CQA management apprised of processes and system status and compliance issues through periodic reports and KPIs
The ideal candidate will ideally bring the following skills and experience:
- Undergraduate degree in life sciences or equivalent
- 3-5 years in pharmaceutical industry / CRO with SOP management experience
- Ability to independently manage processes within electronic quality management systems (SOPs, LMS, e-docs)
- Strong knowledge and understanding of GCP and GVP regulations
- Fluency in spoken and written English (advanced / mother tongue level for written English), any other language is an advantage
- Proficiency in the use of relevant computer systems including complete Microsoft office suite (Visio and MS Project included)
- Experience with regulatory inspections and inspection readiness (preferred)
- Ready to travel, as some travel is required (up to 10%)
You have strong interpersonal, written and oral communication skills at all levels and are able to build partnerships and diplomatically work with other departments. You have «can do» attitude, are a team player and act as a role model for others in line with Vifor Pharma values.
Vifor Pharma Group, formerly Galenica Group, is a global specialty pharmaceuticals company that researches, develops, produces and markets its own pharmaceutical products and is the partner of choice for innovative, patient-focused solutions. The companys goal is to be a global leader in iron deficiency, nephrology and cardio-renal therapies and strives to help patients around the world with severe and chronic diseases to lead better, healthier lives.
Vifor Pharma Group has production sites in Switzerland and Portugal as well as a dynamic network of affiliates and partners offering broad market coverage all over the world.
The company has an ever-growing global presence while at the same time remaining firmly rooted in its home market, Switzerland.
Vifor Pharma Group consists of Vifor Pharma; Vifor Fresenius Medical Care Renal Pharma, its joint company with Fresenius Medical Care; Relypsa; and OM Pharma.
For more information, please visit: http://www.viforpharma.com/en/about-vifor-pharma/who-we-are