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Quality Project Specialist (m/f) Job ID: 10512

Projekt Consulting

Our customer is a leading pharmaceutical company based in Basel, Switzerland.

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
  • 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)
  • File and archive documents owned by QA (e.g. audit reports, CoAs, CoCs, BRR
    sheets etc)
  • Act as a contact person to the needs of the line unit
  • Support the line function in the use of GMP relevant IT tools and processes
  • Collaborate with other associates to support the service function of QA
  • Contribute to the evaluation of new tools
  • Participate in knowledge exchange in TRD
  • Participate in training of new and temporary employees
  • Reviews/Approves 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)
  • Compiles GMP relevant documents in own area of responsibility (e.g. CoC’s, BRR sheets)
  • Receives incoming documents (e.g. executed batch records, work orders, vendor labels, packaging instructions etc.) and performs documentation in respective tools
  • Prepares documentation needed for the batch record review (e.g. Analysis Reports, specifications for clinical development, country label approval etc.)
  • Scans documents, archives in iRelease, distribution
  • Files and archives documents owned by QA (e.g. CoC’s, BRR sheets)
  • Contributes to First Time Right performance reports for release of IMPs
  • Supports QA & DSM in process improvements and in Quality & Compliance issues
  • Fulfills SME role as defined in the QA DSM SME matrix.
Ihr Anforderungsprofil
  • Basic degree in laboratory, manufacturing or relevant discipline (apprenticeship or equivalent)
  • Fluent in site language (German),
    English required (adequate knowledge oral & written)
  • At least 2 years of relevant experience in a corre- sponding 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
  • Good organizational skills
  • Ability to analyze and evaluate GMP compliance
  • Knowledge and flexibility to work with relevant IT systems
Auf Anfrage
Auf Anfrage
Dominik Reinelt
Fon +41 41 510 04 90
Mobil +49 152 338 598 09
Dominik Reinelt
Fon +41 41 510 04 90
Mobile +49 152 338 598 09
Mail dominik.reinelt@theentourage.ch
Betreff Bewerbung für Job ID 10512 auf theentourage.de