QA/QC Specialist (Techn. Research Development) (m/f)

REFERENZNUMMER:

273687/11

IHRE AUFGABEN:

-Manage portfolio of projects, support a discipline and/or provide a service - if applicable, may provide functional expertise in area of responsibility
-Review and recommend disposition of deliverables (e.g. procedures, records, third party work, contractors, clinical trial material, components) to ensure GMP compliance
-QA and QC of primary and secondary packaging
-Perform inspections and audits as required
-Write GMP relevant documents in own area of responsibility (e.g. SOPs with global applicability)
-Meet internal and external guidelines regarding quality and safety (quality manuals, regulatory cGMP guidelines, health authority guidance, SOPs, HSE etc.)

IHRE QUALIFIKATIONEN:

-Bachelor or Master degree in Sciences or relevant discipline
-Good knowledge of English (oral and written) required; fluency in another language (German)
-Good ability to analyse and evaluate GMP compliance
-Sound scientific, technical and regulatory knowledge in a specific area
-Very good knowledge of cGMPs, working knowledge of safety and environmental regulations and

guidelines -Good knowledge of drug development

WEITERE QUALIFIKATIONEN:

Quality management employee