Quality Systems Specialist ITOT

Quality Systems Specialist ITOT: Manufacturing analytics / SingleLIMS / Quality control / GMP / Labware / IPC/ QC / Master data maintenance / Product Lifecycle / English / German

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

The perfect candidate:

The perfect person for this position has a completed university degree in natural sciences or technology (e.g., pharma or chemistry) as well as 1 to 3 years of professional experience in pharmaceutical quality control or production under GMP conditions. Profound practical experience in master data maintenance - ideally with LIMS such as Labware - and pharmaceutical analytics (IPC/QC) is sought in order to reliably take over the 1st level support. In addition to an independent, structured way of working under tight timelines, a high service orientation, strong communication skills and fluent German (C1) characterize the profile. English skills, experience in the field of Business Analytics as well as familiarity with Roche-internal systems are an advantage.

Tasks & Responsibilities:

• 1st level support for SingleLIMS for master data-relevant inquiries within your own area of responsibility
• New recording, adjustment and review of master data and methods according to the needs of the customers 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 requirement for this varied position is a completed degree in the relevant fields (Pharma, Chemistry, Process Engineering)
• At least 1-3 years of professional experience in the GMP environment (preferably in the areas of production or quality control)
• Practical experience in the field of pharmaceutical manufacturing analytics (IPC / QC)
• Experience with the maintenance of master data in the GMP environment 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 speaking and writing (C1)

Nice to Haves:

• Basic knowledge of Roche internal systems and project management is an advantage
• Experience in the field of Business Analytics in the GMP Manufacturing or QC environment
• English skills in speaking and writing

Reference Nr.: 925307
Role: Quality Systems Specialist ITOT
Industry: Pharma
Location: Basel or Kaiseraugst
Percentage: 100%
Start: ASAP(
Duration: 12 + Months
Deadline:

If this position has piqued your interest, please send us your complete resume. If this position does not quite match your profile and you would like to receive other positions directly, you can also send us your resume via this ad or to jobs[at]itcag[dot]com.

Contact us for more information about our company, our positions, or our attractive payroll-only program: .

About us:

ITech Consult is an ISO 9001:2015-certified Swiss company with offices in Germany and Ireland. ITech Consult specializes in placing highly qualified candidates for temporary staffing in the fields of IT, life sciences, and engineering. We offer temporary staffing and payroll services. This is free of charge for our candidates, and we do not charge any additional fees for payroll services.

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