Lab manager állások Külföldön (minőségbiztosítás)

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....

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...

• 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)

CSV ManagerYou 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....

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...

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...

• 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

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...

• 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

• Provide guidance on regulatory and quality requirements, including MDR and FDA requirements, for our in-house and our customer software projects
• Create technical documentation for our industry projects together with our software development teams

• Batch record review for API and bulk product for monoclonal antibody prefilled syringes
• Assessment and documentation of product deviations, OOS, and changes
• Quality oversight for relevant service providers, including CMO's, laboratories, technical operations and supply chain

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

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)...

• 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

Define and lead the global Clinical Affairs strategy for Brainlab's global surgery portfolio, ensuring alignment with product, regulatory and commercial objectives / teams...

Lead and coordinate the Site-Launch activities and associated teams for internal and external sites and development projects...

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...

• Coordinate alliance management activities and ensure adherence to contractual commitments
• Support (and later) lead contract-related updates, including tracking and initiating required changes
• Contribute to achieving key alliance business objectives