Quality Project Specialist (m/f)

REFERENZNUMMER:

359129/11

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
-Review/ approve GMP relevant documents (e.g. work orders, packaging master documents, clinical study labels, batch records for packed material for both packed material from internal or contractors, Notifications of Extension to be issued due to revised expiry dates, analytical documentation for post-packaging-analysis)
-Clarify simple deficiencies in GMP documents with the line unit experts in own responsibility
-Recognize complex deficiencies in GMP documents, report them to supervisor, suggest actions and supervise agreed follow-up
-Provide support for quality relevant electronic systems
-Write and complete GMP relevant documents in own area of responsibility (e.g CoAs, CoCs, BRR sheets, test scripts, SOPs)
-Support the line function in the use of GMP relevant IT tools and processes
-Prepare documentation needed for the batch record review (e.g. Analysis Reports, specifications for clinical development, country label approval etc.)
-Support QA & DSM in process improvements and in Quality & Compliance issues

IHRE QUALIFIKATIONEN:

-Basic degree in laboratory, manufacturing or relevant discipline (apprenticeship or equivalent)
-B.A., B.Sc. or equivalent in science of relevant discipline
-Fluent in site language (German), English required (adequate knowledge oral and written)
-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
-Detailed knowledge of cGMPs, working knowledge of safety and environmental regulations and guidelines
-Basic knowledge of drug development
-Ability to analyze and evaluate GMP compliance
-Knowledge of relevant IT systems

WEITERE QUALIFIKATIONEN:

Quality manager