Ik zoek kandidaten met ervaring met het schrijven van Quality reports (naast andere taken):
* Performs QC/QA investigations, impact assessment (product, process, validation, etc.), Root Cause Analysis (RCA), investigation protocols and reports related to deviations;
* Responsible for management of QC/QA changes and deviations (such as analytical procedures and changes/deviations within operations) including writing and updating documents and associated analysis data sheets according to MMD-GCM. Responsible for the validation of Excel sheets (conform SDLC) and is responsible for the coordination, documentation and transfer tests;
* Documentation coordination and administration related to QN's, CAPA's and QC/Qa projects in compliance with site SOPs, Company Guidelines/ Procedures as well as agencies regulation supporting business goals;
* Responsible for compendia updates (USP, EP, BP, CP, etc.) of analytical methods, including compendial acceptance criteria of analytical techniques, sampling, reporting, and statistical analysis of analytical results;
* Participates in site audits, regulatory and corporate inspections including support to audit responses as required as an SME (Subject Matter Expert).
Geïnteresseerd of ken je iemand in je netwerk die bij dit profiel aansluit? Ik hoor graag van je!
Elke van den Boom
e.vandenboom @ progressive-nl.com of 020 530 5888
Sthree Holland is acting as an Employment Business in relation to this vacancy.