Quality Project Specialist

Harvey Nash is looking for a Quality Project Specialist for a 10 month project in Switzerland.

The role is for a candidate to support the supervisor in the timely release of GMP relevant documents and to support departmental projects and objectives according to agreed timelines and standards in the given area of competency and support adherence to compliance with GMP.

You are responsible for:

. Reviewing/Approving GMP relevant documents (eg 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).
. Compiling GMP relevant documents in own area of responsibility (eg CoC's, BRR sheets)
. Receiving incoming documents (eg executed batch records, work orders, vendor labels, packaging instructions etc.) and performing documentation in respective tools
. Preparing documentation needed for the batch record review (eg Analysis Reports, specifications for clinical development, country label approval etc.)
. Scanning documents, archives in iRelease, distribution
. Filing and archiving documents owned by QA (eg CoC's, BRR sheets)
. Contributing to First Time Right performance reports for release of IMPs
. Supporting QA & DSM in process improvements and in Quality & Compliance issues
. Fulfilling SME role as defined in the QA DSM SME Matrix.

Requirements

. Minimum: Basic degree in laboratory, manufacturing or relevant discipline (apprenticeship or equivalent)
. Desirable: Basic degree in science of relevant discipline (B.A., B.Sc. or equivalent)
. Fluent in site language (German), English required (adequate knowledge oral & written)
. At least 2 years of relevant experience in a corresponding line unit function (eg 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.
. Good organizational skills.
. Ability to analyze and evaluate GMP compliance.
. Knowledge and flexibility to work with relevant IT systems.

Are you available immediately, have experience working within a Life Science company?

Please send your complete CV (Word documents preferred). For further details feel free to call me. I am looking forward to receiving your application.