Junior tréner állások Külföldön (minőségbiztosítás)

• 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....

Product Manager - Biopharma Process Analytics% (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 fields of ventilators, automated pipetting, sample management...

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

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...

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

• 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

Lab Technician Product ValidationBÜHLMANN Laboratories AG is an internationally operating Life Science company that supports clinical laboratories with innovative diagnostic products and first-class services, empowering healthcare providers to deliver more accurate diagnostics for patients...

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...

Head of CMO ManagementmyLife Diabetes Care AG is a new, fast growing independent medtech company specialized in the treatment of diabetes through advanced insulin pump systems. We are looking for an experienced professional who will be responsible for managing our Contract Manufacturing...

• Ensuring process adherence for the pre-market procedures
• Completeness of design history files and regulatory submissions
• Regulatory and process conformance for development and maintenance projects as a member of cross-functional teams

• 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...