Quality System Specialist

ITech Consult AG; Basel; Vor Ort; CHF 90.000 - 120.000; Vollzeit

Zusammenfassung

ITech Consult AG seeks a Quality Systems Specialist ITOT to support manufacturing analytics and GMP-related master data tasks. The role focuses on LIMS (Labware), MES, and ERP data maintenance, with strong emphasis on regulatory compliance and SOP development.

The candidate should have a degree in pharmaceuticals/chemistry/process engineering and 1–3 years of GMP experience, including IPC/QC analytics. German proficiency at C1 level is required; English is a plus.

Qualifikationen

• Degree in pharmaceuticals, chemistry, or process engineering.
• 1–3 years of GMP experience, preferably in production or quality control.
• Experience with pharmaceutical manufacturing analytics (IPC/QC).
• Experience maintaining master data in GMP environments (LIMS/Labware, MES, ERP).
• Independent, structured, proactive work style with strict timelines.

Aufgaben

• 1st level support for Single LIMS and master data inquiries within the area of responsibility.
• Initial recording, adaptation and review of master data and methods per customer needs or regulatory requirements.
• Review of sampling plans and communication of requirements to the business.
• Creation and updating of SOPs and other GMP documents.
• Acting as interface between customer and global IT (developers, 2nd/3rd level support)

Kenntnisse

GMP experience

Master data management

Analytical skills

Communication skills

Customer service orientation

German language (C1)

Ausbildung

Degree in pharmaceuticals/chemistry/process engineering

Tools

Labware LIMS

MES

ERP systems

Jobbeschreibung

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

Tasks & Responsibilities:

• 1st level support for Single LIMS for master data-related inquiries within my own area of responsibility
• Initial recording, adaptation 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
• Creating and updating concepts, standard operating procedures (SOPs) and other relevant GMP documents
• Interface between the customer (business) and global IT (developers, 2nd/3rd level support)

Must Haves:

• A completed degree in relevant fields (e.g., pharmaceuticals, chemistry, process engineering) is required for this varied position.
• 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 analysis (IPC / QC)
• Experience with maintaining master data in a GMP environment, e.g., with LIMS (Labware), MES, ERP.
• Independent, structured, and proactive work style; precise work under strict timelines and multiple parallel tasks.
• Communication and organizational skills and a confident demeanor
• High customer/service orientation
• Excellent German skills, both spoken and written (C1)

Nice to Haves:

• Experience in business analytics within a GMP manufacturing or QC environment
• English language skills, both spoken and written