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...

• 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...

• 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

• 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

• 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