Language

Quality Specialist TRD GCS

QA
Packaging
Batch Records
Batch Record Review
GMP
CGMP
Clinical Study
Drug Development
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 and support adherence to compliance with cGMP in TRD.

Individual specific tasks:

  • Receives incoming documents (e.g. executed batch records, work orders, vendor labels, packaging instructions etc.). Performs documentation in respective tools. Prepares documentation needed for the batch record review (e.g. Analysis Reports, Specifications for clinical development, country label approval etc.).
  • Support the timely release of GMP batches of labels, primary packed materials and Investigational Medical Products.
  • Review and approve GMP relevant documents, e.g. work orders, packaging master documents, clinical study labels,... Batch record review for both packed material from internal or contractors. Compiles, Notifications of Extension to be issued due to revised expiry dates. GMP relevant documents in own area of responsibility (e.g. CoC's, BRR Checklists).
  • Scan, file and archive documents owned by QA (e.g. Certificate of Compliance, Batch Record Review Checklists).
  • Write and review procedures and forms related to the QA Batch record Review Process.
  • Contributes to Right First Time performance reports for release of IMPs.
  • Supports and collaborates with QA & GCS Line Unit in process improvements, Quality & Compliance issues and in the use of GMP relevant IT tools and processes.
  • Support the use, improvement, evaluation and implementation of GMP relevant IT tools and processes.

Requirements:

  • Technician or Bachelor ( 3 years’ experience)
  • Fluent in site language German
  • 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: 80% Onsite
Required start date: 1st of June 2025

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
Pay CHF 30.00 - CHF 34.00 Per Hour
Contract Duration 6 month(s)