QA/QC Specialist (m/f)

REFERENZNUMMER:

319240/11

IHRE AUFGABEN:

-Support the supervisor in the timely release of GMP relevant documents
-Support departmental projects and objectives according to agreed timelines and standards in the given area of competency and support adherence to compliance with GMP in TRD
-Perform review of GMP relevant documents for compliance with SOPs across several customer groups
-Recognize complex deficiencies in GMP documents, report them to supervisor, suggest actions and supervise agreed follow-up
-Write and complete GMP relevant documents in own area of responsibility

IHRE QUALIFIKATIONEN:

-Basic degree in laboratory, manufacturing or relevant discipline
-Fluent in site language, English required (adequate knowledge oral & written)
-A solid experience in a corresponding line unit function (e.g. laboratory, manufacture, packaging, IT, documentation)
-Communication skills to sufficiently address GMP and logistic related questions with the line unit experts, in order to maintain GMP records in a compliant status
-Scientific, technical and regulatory knowledge in a specific area
-Basic knowledge of drug development
-Ability to analyze and evaluate GMP compliance

WEITERE QUALIFIKATIONEN:

Quality manager