Senior regulatory reporting associate állás, munka

• Operational management of the company’s quality assurance system as the Qualified Person (Responsible Person).
• Supervision of quality assurance processes at partner companies and within the group’s sites.

• Support planning, tracking, and assembling regulatory content for simple submissions
• Manage operational tasks such as document retrieval, submission creation, and delivery
• Coordinate with global teams to maintain timelines and compliance

For our partner located in the canton of Bern, GI Life Sciences is looking for a: SENIOR SCIENTIST BIO-/CHEMICAL QUALITY CONTROL Start : Mid-November End : YOUR MISSION : As a SENIOR SCIENTIST IN BIO-/CHEMICAL QUALITY CONTROL, you will play a key role in establishing the BCQC unit within the...

Develop and implement DSS cross-functional technology infrastructure strategy, ensuring alignment with business needs and stakeholder engagement, including Clinical Data Science, Data Engineering, Statistical Programming and Biostatistics...

Development of product strategies for existing and new portfolios, including market research to identify innovation opportunities in lens technology and design, as well as defining product specifications and managing the product lifecycle...

• 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

• 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

• 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

• Lead Scientific Discovery 
• Drive independent programs to identify novel plant species with untapped potential for PhytoComplex development 
• Establish innovative analytical methodologies for characterizing complex bioactive compounds using advanced techniques including chromatography and spectroscopy 

• 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.)