QA Lab and Data Integrity Management Car-t
il y a 4 semaines
The Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting a QA Lab and Data Integrity associate for the CAR-T hub in Europe. The position will be based in Gent Belgium.
CAR-T (chimeric antigen receptor T-cell therapy) is a new way to eliminate cancer cells, which work by harnessing the power of a patient’s own immune system. The patients’ own T cells are harvested and engineered to kill the cancer cells expressing a specific antigen.
To bring this life saving therapy to the patients, Janssen is looking for new talents to support the CAR-T organisation So don't hesitate the patients are waiting
The QA Lab and Data Integrity Associate CAR-T is responsible for providing quality oversight of Data Integrity compliance for both manufacturing and lab equipment for the CAR-T cellular therapy in accordance with Janssen policies, standards, procedures, and Global cGMP’s.
**Key Responsibilities**:
- Provide Data Integrity compliance oversight for the QC laboratories and cell therapy manufacturing area. Support in building and implementing all Data
Integrity processes to ensure compliance.- Ensuring accurate and timely review of investigations, performing analysis on quality indicating data and identifying any trends noted.
- Provide compliance and quality oversight for Lab instrument qualification
- Support drafting and approving of standard operating procedures.
- Ensure non-conformances are investigated thoroughly and approved in a timely manner and appropriate corrective and preventive action plans are
implemented.- Strive to reduce non-conformances in supported areas by proactively driving compliance.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
- Critically support investigations and reports, interpret results, and generate technical conclusions consistent with quality risk management principles.
- Recognize patterns and trends in reported data and communicate to management.
- Routinely recognize and resolve quality issues. Seeks management guidance on complex issues. Develops procedures.
- Be able to interpret complex results and situations with degree of independence and articulate recommendations for solutions. Identifies risk and develops contingency plans.
- Drive continuous improvement.
**Qualifications**:
- Required:
- A minimum of a Master Degree in Engineering, Science or equivalent technical area is required.
- 1-3 years of experience in a GMP and QA environment
- Knowledge of Annex 11 and 21CFR part 11 regulations
- Preferred:
- Experience in Equipment qualification is prefered
- Experience in CSV is prefered
- Experience in cell culture is preferred
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