Site reliability engineer állások, munkák egészségügy, gyógyszeripar területen

• Receipt / Download / Accepting of cases from Document Exchange Tool or electronically (or any other source)
• Translation of all relevant European Non-English information from source documents to English (if required) and updating relevant fields in Standard Adverse Event (AE) form

• 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

• 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

• 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

• 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 

• 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

• Coordination of the (partial) project to establish and continuously expand the EU reference network with all participating centres and clinics at EU level
• Participation in the helpdesk for the network's eHealth service
• Work with the project management team on the progression of the clinical registry

• Perform release and stability testing of antibodies, proteins, and peptides using capillary electrophoresis techniques (e.g. CE-SDS, cIEF, CZE) in a GMP-compliant laboratory
• Conduct analytical method validations
• Document all work accurately in LIMS, Chromeleon and on paper

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

• 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 strategic sourcing and CDMO site selection, including due diligence
• Conduct price negotiations and manage contracting of CMO agreements
• Drive Supplier Relationship Management (SRM) activities for CMOs
• Develop and operationalize category strategies, buying guides, and best practices

• Operation of a suite of on-line mass spectrometers (ToF-ACSM-X, VOCUS-PTR-MS) and further instrumentation to measure atmospheric composition in the gas and particle phases.
• Operation of offline instrumentation such as filter samplers and cloud water collectors during dedicated campaigns.

• Ensuring process adherence for the pre-market procedures
• Completeness of design history files and regulatory submissions
• Regulatory and process conformance for development and maintenance projects as a member of cross-functional teams

• Lead contamination control program, risk assessments and strategies in line with cGMP, Johnson & Johnson, and regulatory standards.
• Drive initiatives to reduce contamination risks and enhance microbiological hygiene practices.

• Support MED-EL rehabilitation services world-wide
• Provide content and manage the hearing rehabilitation portfolio
• Develop and promote rehabilitation materials, tools, programs, and services for various platforms and media

• A minimum of 10 years of continuous abstinence from all psychoactive substances
• Excellent written and spoken English (C2 professional proficiency); other languages are an advantage

• 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

Leading a team of assigned CRAs across different countries, you coordinate and guide their work to ensure study milestones are delivered efficiently, accurately, and on time...

• Lead, coach, and inspire a global team of Programme Managers - fostering collaboration, accountability, and continuous development
• Oversee customer account allocation and ensure balanced workload distribution and high-quality delivery across the team

• Supporting system-related inquiries by analyzing and evaluating system errors and user requests for improvements and implementing solutions in collaboration with IT teams.
• Creating and revising work instructions.