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Quality Systems Specialist ITOT

ELAN Personal AG

Employment type
Full-time
Workload
100%
Location
Basel
Company
ELAN Personal AG, Leimgrubenweg 16, 4053 Basel
First posted
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Quality Systems Specialist ITOT
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Roche Switzerland bridges the gap between pharmaceuticals and diagnostics. Important research and development functions are located here. For our long-standing client, F. Hoffmann - La Roche AG in Basel, we are looking for a

Quality Systems Specialist ITOT
===================================

Background:

The 'Laboratory & Manufacturing Systems Support' group of the ITOT department in Basel (work location is Kaiseraugst & Basel) is responsible for the 1st level support of the MAR (make, assess, release) relevant quality systems Batch Release Hub, MPC and SingleLIMS and for the maintenance of master data in SingleLIMS during tech transfers and during Product Lifecycle activities.

In this function, you and your colleagues will ensure that the master data covers regulatory requirements as well as reflects the customers' workflows. Through 1st level support, you will contribute decisively to maintaining the lead time regarding the production and release of products.

Tasks & Responsibilities:

  • 1st Level Support for SingleLIMS for master data-relevant inquiries within your own area of responsibility
  • New entry, adjustment and review of master data and methods according to customer needs or regulatory requirements
  • Review of sampling plans and communication of requirements to the business
  • Creation and updating of concepts, working instructions (SOPs) and other relevant GMP documents
  • Interface between the customer (Business) and global IT (developers, 2nd/3rd Level Support)

Must Haves:

  • A prerequisite for this varied position is a completed degree in the relevant fields (e.g. Pharma, Chemistry, Process Engineering)
  • At least 1-3 years of professional experience in a GMP environment (preferably in the areas of production or quality control)
  • Practical experience in the field of pharmaceutical manufacturing analytics (IPC / QC)
  • Experience in the maintenance of master data in a GMP environment, e.g. with LIMS (Labware), MES, ERP
  • Independent, structured, and proactive way of working, precise work under strict timelines and multiple parallel tasks
  • Communicative and organizational skills and a confident appearance
  • High customer / service orientation
  • Very good German skills in spoken and written (C1)

What is offered to you:

  • A chance to contribute to one of the most significant pharmaceutical companies in the world
  • Modern campus with lots of green spaces and meeting zones
  • Varied activity profile
  • Further training opportunities through temptraining
  • Collaboration in a dynamic and motivated team

You are welcome to send your complete application documents to Ms. Diana Afonso.

Basel Basel-Land Aargau Chemistry Pharma IT ITOT Chemistry Process Engineering SOP GMP LIMS

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