Senior python developer állás, munka

SENIOR DATA SCIENTIST - LITERATURE (M/F/D)-INFORMATION SCIENCE/ PHARMACEUTICAL/ RESEARCH/ DEVELOPMENT/ PHARMACOVIGILANCE/ MEDICAL/ DRUG/ BIOMEDICAL/ SYNTHESIZE SCIENTIFIC DATA/ COMPETITOR INFORMATION ACCESS PLATFORM/ DIALOG/ ENGLISH PROJECT: For our pharmaceutical customer based in Basel, we are...

End-to-End Project Management: Lead CMC development programs from initiation to execution, maintaining operational and financial control through detailed plans, timelines, budgets, milestones, dashboards, and forecasts....

• Develop and implement global regulatory pathways for product authorizations
• Oversee preparation and submission of regulatory documents to authorities

POSITION DESCRIPTION We are seeking an experienced and motivated professional to join our software quality assurance team. In this key role, you will help ensure compliance with IVDR, FDA 21 CFR Part 820, and cybersecurity requirements for medical device software. - Partner with development teams...

• Independently lead cross-functional teams through the full product lifecycle-from concept to market launch, ensuring alignment with business strategy.
• Lead and deliver complex hardware and software automation development programs with global impact.

• Management of deviations, change requests as well as corrective actions and preventive actions
• Review of equipment qualifications, batch documentation, and product release preparations for clinical studies

• Start Date:or
• Latest Possible Start:
• Duration: 6 months initially; extension possible (e.g., additional 6 months)
• Location: Basel
• Workload: 100%
• Home Office: Yes
• Travel: Not expected
• Team Size: PCS safety team approx. 6; cross-functional project teamsmembers
• Hiring Manager: Simone Melega

• Providing ready to implement vision science concepts for development of digital measurement / digital fitting solutions
• Self-organized, constantly screening, analyzing, monitoring and testing of latest global developments and industry trends in vision science

• Responsible for processing incoming complaints in accordance with applicable process specifications
• Independent processing and assessment of complex or critical complaint cases with potentially high risk to patient safety or regulatory compliance

• Collect various samples (blood, saliva, urine, hair), conduct breathalyzer tests, and provide wound care
• Perform medical and BIO-R check-ups, including BMC measurement, EKG, vitals, and medication documentation
• Administer infusions and injections as needed

• 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

• 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

• 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.)

• Leading the development of the faculty's research strategy and building a strong interdisciplinary team.
• Establishing translational research projects within SFU MED and in collaboration with national and international partners.

Strategic Influence: Shape the success of the TRICARE Overseas Program by building and nurturing high-level relationships with military and civilian partners....