Software developer m f d állások, munkák minőségbiztosítás kategóriában

• Planning and initiation of business cases, definition of the project scope, objectives and deliverables. This includes gathering requirements, assessing feasibility and developing a project plan that aligns with organizational goals
• Monitoring of timelines and budget

PHARMACOEPIDEMIOLOGIST (M/F/D)- RWD/ EPIDEMIOLOGICAL/ PHARMACOEPIDEMIOLOGIC/ CLINICAL TRAILS/ BIOMARKER/ INSURANCE CLAIMS/ EHR/ MEDICAL/ MEDDRA/ SNOMED/ ICD 10/ CPT/ HCPCS/ R/ PYTHON/ SQL/ DATA VISUALIZATIONS/ R SHINY/ R MARKDOWM/ STATISTICAL ANALYSIS/ ENGLISH PROJECT: For our customer a big...

Provide strategic statistical consultation and hands-on implementation of advanced methodologies to optimize clinical trial designs and data analytics;...

• 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

Serve as the medical device subject matter expert to both internal and external customers for product development, risk assessment, training, implementation, literature reviews, complaints, safety signals, field action, voice of the customer, and voice of the business....

• 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

• 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

• 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

• Responsible for the functionality, data quality, compliance, and user-friendliness of RIMS and eCTD systems.
• Ensuring the operation, maintenance and further development of the systems (Extedo eCTDmanager, Veeva RIM).

• Lead and support cross-functional projects in regulatory affairs and quality management.
• Identify, interpret, and implement regulatory requirements across global markets, with a strong focus on international registrations outside the U.S. and EU.