BE - Quality Assurance CAR-T

Your responsibilities and your Impact:

• Responsible to integrate quality standards to mitigate failure mode risks during risk-based assessments in the asset management design reviews

• Responsible to ensure compliance of qualification activities. ·Responsible for review and approval of qualification documents.

• Responsible for review and approval of certification master data. · Responsible for review and approval of master data E6 notifications (eStream), change controls records and quality issue/investigation records, including corrections and CAPAs during execution of qualification activities and during the life cycle of the facility, system andequipment.

• Maintain a current knowledge of international regulations, guidelines and industry practices related to system qualification

• Participate in system introduction and system change projects and assure quality and compliance aspects.

• Ensuring that all system changes that may have impact on quality, compliance or registration, are evaluated and approved in order to execute adequate control, documentation and qualification.

• Review and approval of qualification documents such as (system level) Impact Assessment ((SL)IA), critical aspect risk assessments (CARA), (General) User Requirements, DQ/IQ/OQ/PQ protocols & reports, QSR, Test- and traceability matrices for compliance to regulations, guidelines and J&J procedures.

• Review and approval of Periodic System Quality Reviews and Area Validation Master Plans (VMPs) · Ensuring that deviations related to systems with possible impact on quality and/or compliance are evaluated, thoroughly investigated and that adequate corrective and preventive actions are implemented.

• Responsible for review and approval of calibration/certification procedures, calibration rationales, calibration master forms and completed calibration records.

• Responsible for review and approval of parameter lists, alarm lists and transmission lists and other documents in eSTREAM

• Responsible for review and approval of qualification / system related procedures/work instruction.

• Make sure that all deliverables out of qualification are implemented in the quality systems: SOPs, Work instructions, Calibration records, Maintenance plans

• Prepare for regulatory and customer inspections and act as a spokesperson for QA qualification related matters during audits

• Pro-actively and continuously challenge the quality of the qualification processes to improve the performance of qualification and develop and implement improvements. cGxP / ATMP · Always uses the appropriate cGxP / ATMP and procedures.

• Proposes solutions to improve compliance with cGMPs. Safety, Health & Environment (SHE)

You will be required to travel to Beerse and Ghent.

Education and Experience Required for Role:

• +5 years experience in the Pharmaceutical industry

• Thorough knowledge of pharmaceutical legislation, cGMP regulations and guidelines in the area of system qualification

• Knowledge of the different systems used during the manufacturing process

• Strong analytical thinking, risk assessment and communication skills.

• Collaboration and teaming skills · Mindset for innovation and optimization

• Master Engineering, Pharmacy or equivalent degree

• Fluent in Dutch and English (written and spoken)

Things to remember before applying for this role:

• We do not accept applications via email.

If you are interested in this role please apply now! Make sure you fill out your application in full, your personal CV will be used for the recruiter’s reference only, they are not sent to Hiring Managers. Ensure all relevant information is included in your application! 

Thank you very much and we look forward to receiving your application.

Questions

If you would like some additional information about the role please contact: bdardenn@its.jnj.com (please note that we do not accept applications via email).

Diversity, Equity & Inclusion:

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences

That is why we in Belgium are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.