Senior kontroller állások Svájcban (egészségügy, gyógyszeripar)

• 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

• Market & Revenue Development: Implement market entry strategies and acquire international patients (B2C) as well as strategic partners (B2B)
• Market Analysis: Conduct market research, evaluate opportunities, and assess regulatory and competitive landscapes

Networking - You enjoy maintaining and expanding your network of decision-makers in the healthcare industry. You utilise your contacts to generate leads and gather information....

• 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.

• Master's degree in Life Sciences, Biology, Chemistry, Pharmacy, Engineering or Law
• Native German speaker with strong English skills (C1)
• 3+ years of experience in GMP deviation & CAPA management
• Strong IT skills

Medical Device Clinical Safety Scientist (m/f/d)- Healthcare/ Scientific/ Biomedical/ MDs/ MD Clinical Investigation/ CIP/ Protocol/ IB/ RSI/ Risk Management/ ISO/ Drug/ English PROJECT: For our customer a big pharmaceutical company in Basel, we are looking for a Medical Device Clinical Safety...

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....

• Design, develop, and optimize coagulation diagnostic assays and reagents
• Lead feasibility studies, verification, and validation activities in compliance with ISOand IVDR requirements
• Document all activities according to quality system procedures and design control standards

• 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

• Develop and validate LC-MS methods for the quantification of impurities in complex samples
• Optimize and troubleshoot analytical methods to ensure accuracy, precision and robustness 
• Collaborate closely with cross-functional teams to drive project success

• Interface between construction site and operator
• Support for the existing SHE organization (operator)
• Issuing work permits to contractors
• Monitoring compliance with relevant safety regulations
• Participation in coordination and construction meetings
• Safety inspections as needed

• 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