QA Lab and Data Integrity Management Car-t - Gent, België - Johnson & Johnson

Johnson & Johnson

Geverifieerd bedrijf

Gent, België

1 week geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

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 nonconformances 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.
13 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