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Framework and Content: Develop and maintain global sales capability frameworks, designing high-impact training content (in partnership with external vendors when necessary) focused on product knowledge, clinical confidence, and compliant HCP engagement in the aesthetic space....

• Du hast zum Zeitpunkt des Praktikums das Studium der Pharmazie mit dem 2. Staatsexamen erfolgreich abgeschlossen.
• Eine sorgfältige und gewissenhafte Arbeitsweise, Zuverlässigkeit und Teamfähigkeit zeichnet dich aus.
• Im Umgang mit MS Office und MS Outlook bist du versiert.

JUNIOR LABORATORY TECHNICIAN (M/W/D) - BIOLOGICAL SAMPLES / GXP / SAMPLEPREPARATION / ENGLISH / GERMAN PROJECT: For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a qualified Junior Laboratory Technician (m/w/d) BACKGROUND: Department: Instrumental Analytics...

• Lead and oversee all clinical safety and vigilance processes for medical devices.
• Manage adverse event assessment and reporting in compliance with global regulations.
• Ensure accurate development and maintenance of RSI, CIP, and IB safety content.

• Leading and advancing chromatographic methods for the characterization of active ingredients, pharmaceuticals, and excipients
• Ensuring robust analytical results with a focus on content determination, degradation products, stability profiles and degradation pathways

Provide expert leadership and oversight for all clinical safety and vigilance activities associated with Class II and/or III Medical Devices (MD), ensuring adherence to global regulatory requirements and internal standards throughout the product lifecycle....

• In-process controls, release and stability tests using HPLC-based analytical methods 
• DLS-based analyses; pH, IR, and wet chemical analyses
• Visual appearance test of finished drug product for batch release and stability 

Subject-Matter Expert (SME) for Test Method Development of delivery devices and combination products: Test Method development, including best practices for universal implementation, Test Method Validation/Transfer....

• Developing and maintaining sterility assurance and contamination control strategies for aseptic processing
• Leading risk assessments for aseptic process, single use systems and critical interventions, and ensuring compliance with authorities relevant Guidance such as Annex 1

• Strategic Sourcing / CDMO Site Selections including Due Diligence
• Price Negotiation
• Contracting of CMO contracts
• SRM Activities for CMOs
• University degree a scientific or business field or similar
• Min. 5 years relevant experience CMO Management or procurement in CMO space 
• GMP Experience 

• Perform analyses of finished products, samples in progress, raw materials, excipients, cleaning samples, validations and environmental monitoring according to established procedures.
• Ensure the maintenance and proper functioning of the BCQC laboratory equipment.

• You are responsible for quality related topics like change control, deviations and/or complaints related to DS products at CMOs
• Define together with the CMO effective CAPAs and track the timely implementation

lead the planning, execution, and monitoring of clinical trials to ensure compliance with regulatory requirements and company standards...

• Focus of this position is supporting our rapidly developing in Diabetes Care (active and connected devices)
• Manage the development and implementation of RA strategies
• Support and prepare product submission documents with main focus on US
• Partner with business stakeholders on different levels

Prepare, support the creation and review and execute the release of all technical documentation for digital health and software products ensuring compliance with applicable standards and regulatory requirements such as IEC, IEC...

• Contribute to all phases of medical device development, from architecture concepts to design verification and design transfer
• Design and develop low-power medical embedded systems, with a strong focus on safety, reliability and regulatory compliance (IEC13485, IEC60601, ISOetc.)

• Responsible for the functionality, data quality, compliance, and user-friendliness of RIMS and eCTD systems.
• Ensuring the operation, maintenance and further development of the systems (Extedo eCTDmanager, Veeva RIM).

• You ensure that each batch is manufactured and tested in accordance with legal regulations
• You approve or reject bulk and finished products and sign the corresponding test protocols
• You approve specifications, sampling instructions, and testing instructions and ensure compliance with them

• Manage and control the entire artwork lifecycle for externally developed packaging artworks. 
• Coordinate artwork creation, updates, and approvals across internal and external stakeholders. 
• Track change requests and ensure timely implementation of updates.