Sap junior tanácsadó állások Külföldön (minőségbiztosítás)

• Driving supplier performance improvement through root cause analysis, corrective action and supplier performance reviews;
• Ensure compliance with the European Medical Device Directive and associated regulations;

Development Operations Manager (ATMP) (Geneva, CH | 80%-100% FTE | Hybrid/Remote Possible)About the CompanyRelease Therapeutics SA is a Switzerland-based biotechnology company developing an Advanced Therapy Medicinal Product (ATMP) program in the CNS and beyond. We operate with a very lean internal...

• Plan and Conduct GCP Audits: Develop a risk-based audit schedule covering all relevant areas, including investigator sites, vendors, and internal processes, to ensure adherence to GCP guidelines
• Oversee Corrective and Preventive Actions (CAPA) specific to GCP (internal or external)

Plan, Conduct, and Follow Up on Pharmacovigilance Audits including oversight and training of external service providers and consultants (for audits), ensuring adherence to company standards and regulatory requirements...

Risk-Manager% (f/m/d)True to the vision "We drive innovation to improve people's lives", the Hamilton companies have been providing solutions for the health sector sinceWe are an innovative pioneer in the field of ventilators.Hamilton Medical is a leading manufacturer of intelligent ventilators....

CSV EngineerYou can find all of our job offers by clicking here: /.Teoxane Laboratories were established in Geneva, Switzerland, inThey are specialized in the design and manufacturing of hyaluronic acid-based dermal fillers and dermocosmetics. Teoxane strength is to offer a global patient care....

• Lead strategic relationships with CMOs to improve cost, quality, delivery performance and innovation (annual spend $60-70M)
• Conduct regular business reviews (SRM) and monitor KPIs, performance metrics, and contractual compliance

• Maintain and further develop our QMS in line with EN ISO 13485 and MDSAP
• Create, update, and improve procedures, forms, and training materials
• Plan and deliver training on procedures and regulatory requirements
• Lead and oversee CAPA initiation, processing, tracking, and review

Unterstützung innerhalb der F&E-Abteilung/Einführung neuer Produkte (Neuproduktentwicklung und Innovation) und anderer geschäftskritischer und/oder umsatzfördernder Maßnahmen von der Planung bis zur Kommerzialisierung...

Creation, editing, and review of all quality documents (DEV, CAPA, CCO, maintenance completion reports) in accordance with SOP specifications...

Technical Support Manager API (f/m/d)%The IMCD Group is a global market leader in the sales, marketing and distribution of specialty chemicals and ingredients. With a global network of industry experts, IMCD offers its suppliers and customers in the EMEA, Americas and Asia Pacific regions...

• Global pharmacovigilance product responsibility for the medicinal products
• Monitoring of the benefit-risk profile
• Signal management: signal detection, signal validation, signal evaluation
• Risk management: preparation of risk management plans, supervision of risk minimization measures

Management of safety operations incl. corresponding service providers, creation and maintenance of reporting rules (in collaboration with the department Global Safety Application Management) and license partner obligations with respective compliance outputs (e.g. KPIs, PSMF)...

Management of safety operations incl. corresponding service providers, creation and maintenance of reporting rules (in collaboration with the department Global Safety Application Management) and license partner obligations with respective compliance outputs (e.g. KPIs, PSMF)...

You develop, maintain, and continuously improve the Quality Management System in accordance with ISO 13485, MDR, and other applicable regulatory requirements...

• Scientific lead and coordination of Critical Quality Attributes (CQA) evaluations and product characterization studies
• Representation of Analytical Science in the customer project teams, coordination of activities and implementation of the QbD strategy

• Develop clinical trial strategies, shaping study designs based on regulatory requirements, competitive insights and company's research interest.
• Give insights into clinical data sets and evidence for our company's products to internal stakeholders.

• Lead the commercial development of profitable lab testing services
• Lead and develop the lab organization
• Monitoring of the laboratory and all work carried out there, to ensure compliance with relevant internal procedures and regulations

Create and/or hold scientific presentations, lectures, training courses, speaker decks, FAQ documents etc. with targeted content for the respective stakeholders...

Manager Product Risk ManagementmyLife Diabetes Care AG is a new, independent Medtech company specialising in the treatment of diabetes using advanced insulin pump systems. For our Product Development Department, we are looking for an experienced Manager who lead and develop the Product Risk...