interviews, process mapping, and current state assessments across CMC Dev laboratories to translate & align needs into clear... trails, etc. ELN structured data structuration: Configure data mapping according to CMC data models ensuring data/metadata...
and CMC Development/CTS colleagues to identify and mitigate Compliance risks, resolve potential regulatory observations...
in leading internal audits/self-inspections. – Familiarity with regulatory submissions and CMC (Chemistry, Manufacturing...
collaboration with the product CMC Quality Leads and the vendors. When applicable, be sure that the Annual Product Stability... Regulatory Affairs and CMC Quality Leads for submission document requests Coordinate legalization/notarization of documents...
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...
of CMC and analytics for late-stage/commercial products;Knowledge of quality and regulatory aspects...