Quality Systems Specialist / Quality Systems Specialist

The Life Science Career Network

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Quality Systems Specialist ITOT

Our client is a pioneer in drug research and development and one of the leaders in personalized medicine. As the world's largest research and development partner in the pharmaceutical and diagnostics industry, the company works on a variety of drugs and therapeutic areas and is highly recognized internationally.

We are looking for a Quality Systems Specialist ITOT for a 12-month assignment (with the option to extend) at the location of Basel or Kaiseraugst, Switzerland. After onboarding, a minimum of 50% on-site presence is required.

The group ‘Laboratory & Manufacturing Systems Support’ 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, as well as for maintaining the master data in SingleLIMS during tech transfers and product lifecycle activities.

In this role, you and your colleagues ensure that the master data meets regulatory requirements and reflects the workflows of the customers. Through 1st level support, you play a crucial role in maintaining the lead time for the production and release of products.

Responsibilities:

• 1st level support for SingleLIMS for master data-related inquiries in your 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, standard operating procedures (SOPs), and other relevant GMP documents
• Interface between the customer (business) and global IT (developers, 2nd/3rd level support)

Qualifications:

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

Nice to Haves:

• Basic knowledge of internal systems and project management is an advantage
• Experience in business analytics in GMP manufacturing or QC environment
• English language skills in spoken and written form

If you are interested in discussing this position with us, please apply online using the form below. Only applications matching the job profile will be considered.