Qms Specialist

il y a 2 semaines

Gent, Belgique Legend Biotech EU Temps plein

**Company Information**

Legend Biotech entered into a global collaboration agreement with Janssen Biotech, Inc. to develop, manufacture and commercialize ciltacabtagene autoleucel (cilta-cel). Through our strategic partnership, we look to advance the promise of an immunotherapy in the treatment of multiple myeloma.

**Position Overview**

The QMS Specialist will provide oversight of all GMP documents and ensure that all documents are updated and effective in alignment with the needs of CAR-T Operations and document lifecycle management. They will also be responsible to prescribe the correct training based on the type of changes made. And maintain both the procedures as the trainings in the electronical systems.

**Major Responsibilities**
- Introduction of new SOPs in time to support Manufacturing Strategy.
- Ensure periodic review of all SOPs are completed on time.
- Liaison with all relevant departments to ensure alignment for new SOPs and changes to existing SOPs.
- Ensure procedures are kept up to date in the electronical document management system.
- Ensure proper training is prescribed as per the document changes made.
- Ensure training is added in the electronical Learning management system.
- Build and maintain curricula in the electronical learning management system.
- Continuous improvement of all QMS documents to ensure they are streamlined and robust, easy to use and intuitive; to help ensure maximum prevention of operational errors and quick turnaround times.
- Ensure QMS documents incorporate all latest regulatory and quality requirements and stay current regarding industry standards.

**Qualification**

**Education**:

- Bachelor's degree in Scientific discipline or equivalent work experience in document creation

**Capabilities, Knowledge, and skills**:

- 3-5 or more years of related experience in cGMP/FDA regulated industry is preferred
- Pharmaceutical GMP's - strong knowledge of Good Manufacturing Practices and regulatory knowledge is preferred

**Language(s)**:
Dutch / English

LI-AG1

Legend Biotech maintains a drug-free workplace.

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