van Regulatory CMC-compliance van plantprocessen met de registratiedossiers. Optreden als kwaliteitsautoriteit (cGMP-conform... in de farmaceutische sector en/of medical devices. Ervaring of sterke interesse in Quality Assurance/Compliance en CMC voor (bio...
intersection of science, CMC strategy, client interaction, GMP compliance, and analytical innovation within a fast-paced multi... during project execution. Translate client needs into robust analytical solutions aligned with CMC and regulatory expectations...
-and-error waar nodig;Je hebt voeling met GMP-principes, CMC-vereisten en QC-processen, en past deze pragmatisch toe...), de CMC-context van geneesmiddelenontwikkeling;· Je schakelt vlot tussen strategie en uitvoering;· Je bent...
als centrale schakel tussen interne stakeholders (CMC, operations, QA) en externe partners (CRO's, CDMO's, klinische sites...- en GCP-richtlijnen en bij voorkeur ook kennis van klinische supply (IMP) in een CMC-context van geneesmiddelenontwikkeling...
role As part of Clinical Manufacturing Quality, you act as a Dev Quality Lab Ops Data Integrity Partner supporting CMC... with regulations and policies, coordinating daily QA systems and DI activities. Data Integrity Governance: Leading CMC and CSC data...
support specialist, you will support the CMC analytical scientific integrator in project management, specifications, stability... background (MSc in Science or equivalent with experience in project management in CMC development). Project management skills...
: Budget Management, Chemistry, Manufacturing, and Control (CMC), Clinical Trial Protocols, Critical Thinking, Cross-Functional...
of CMC and analytics for late-stage/commercial products;Knowledge of quality and regulatory aspects...
, and Control (CMC), Cost-Benefit Analysis (CBA), Developing Others, Gap Analysis, Good Manufacturing Practices (GMP), Inclusive...
Labcorp is seeking an onsite EHS Specialist Biological Safety Coordinator to join our new CMC facility and support... BioPharmaceutical Chemistry, Manufacturing and Control (CMC) footprint and is opening a new CMC facility in Mechelen, Belgium...