Language

Quality Specialist TRD GCS

QA
GMP
Drug Development
Environmental Regulations
Risk Assessments
CGMP
Batch Records
Batch Record Review
Description:

This is a temporary contractor opportunity at Novartis 

Novartis touches the lives of a tenth of the world’s population. Every role here, regardless of contract type, makes an impact on human life! 

 Novartis partners with external managed service provider Magnit Global to offer engaging temporary contractor opportunities like this, to those who are looking for flexibility in their career while looking to gain new skills and experiences providing services to an inclusive global medicines company. Click here to learn more about Magnit.

 Ready to work with/through Magnit at Novartis? Please read on…

Role purpose:

Standard activities or routine tasks e.g. batch records reviewer, etc. Supportive project work. Support the timely release of GMP relevant documents and batches. Support departmental projects and objectives according to agreed timelines and standards in the given area of competency and support adherence to compliance with cGMP in TRD.

Main Activities:

  • Support a discipline and/or provide a service individually or within a team of associates. May provide functional expertise to Line Unit and other QA Units in area of responsibility.
  • Write and review GMP-relevant deliverables and/or related tools as per area of responsibility in order to ensure compliance with cGMP and project quality deliverables.
  • Support project related activities (e.g. TRD product portfolio, development of new tools, processes, Quality initiatives, Quality Manual implementation, Quality Plans, Quality Risk Assessments, training activities, qualification and facility upgrade activities, IT validation projects) as per area of responsibility.
  • Comply with internal and external guidelines regarding quality and safety (Quality Manual, regulatory cGMP guidelines, Health Authority guidance’s, SOPs etc.). 

Additional specific roles/tasks:

  • Receive incoming documents (e.g. executed batch records, vendor labels, etc.).
  • Support the timely release of GMP batches of labels, primary packed materials and Investigational Medical Products.
  • Scan, file and archive documents owned by QA. (e.g. Certificate of Compliance, Batch Record Review Checklists)

Ideal Background:

  • Education: Technician (+5 years’ experience); Bachelor (+3 years’ experience)
  • Languages: Fluent in site language, English required (adequate knowledge oral & written).
  • Communication skills to sufficiently address GMP and logistic related questions with line unit experts. Scientific, technical and regulatory knowledge in a specific area.
  • Basic knowledge of drug development.
  • Detailed knowledge of cGMP, working knowledge of safety and environmental regulations and guidelines. 
  • Good organizational skills

    Workload: 100% (40 hours per week)
    Role type: Onsite
    Required start date: January 2026
    Contract: 6 months

Why Novartis: 
Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?

EEO Statement:
The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accommodation: 
If you require reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please direct your inquiries to Magnit at [email protected].

QUALIFICATION/ LICENSURE :
  • Work Authorization : N/A
  • Preferred years of experience : 3+ Years
  • Travel Required : No travel required
  • Shift timings: 9 AM to 5 PM
Job Location Basel, Basel-Stadt
Contract Duration 6 month(s)