Data Integrity and Quality Culture Specialist
Contracting – Walloon Brabant
Your responsibilities?
As Data Integrity and Quality Culture Specialist, you will be our local expert for Data Integrity and Quality Culture.
You will
- Lead the implementation of the data integrity culture and strategy for our site and ensure compliance with global and local regulatory requirements and customer expectations at the system level
- Ensure that best practices are in place and in use, seek for continuous improvement, while ensuring application of the right level (risk-based approach) of quality
- Assure capabilities buildup within the site through effective coaching, monitoring/reporting, and performance management.
Your Major accountabilities will be:
- Definition and follow-up of data integrity & Quality Culture roadmap for the company. To evaluate and lead continuous improvement initiatives (i.e. Site Quality Plan) concerning data integrity & quality culture, to ensure compliance with quality systems, global requirements, regulations, guidelines and customer requirements.
- Developing and maintaining the Quality Management System in relation to data integrity & quality culture: evaluate the performance management of data integrity, make results visible through KPIs and periodic reports.
- To manage the creation, review, maintenance and delivery of Data Integrity & Quality Culture training material, including but not limited to data integrity onboarding, refresh trainings and excel spreadsheet validation trainings. Train and mentor on the job personnel on data integrity & quality culture aspects from onboarding to increased maturity.
- Participate as data integrity & quality culture Subject Matter Expert in deviation investigations applying RCA tools. Propose and implement associated CAPA / improvement actions concerning data integrity & quality culture. Train and coach deviation investigators on the use of Data Integrity RCA tools and investigating human errors.
- To review and maintain documents related to quality culture and data integrity in accordance with current quality system requirements, regulations, guidelines, and customer expectations.
- Establishment and leading an internal site network of DI champions and actively participating in creation of global multi-site DI community of practice within the company group. Be the point of contact for the site within group.
- To perform Data Integrity internal audits and act as an SME during internal and external audits and inspection for Data Integrity & Quality Culture topics, redacting responses and managing the associated follow-up actions.
Your profile?
- Bachelor or Master’s Degree in Biology, Biomedical Sciences, Pharmacist, Bioenginneer or similar
- Proven experience (at least 3 years)in Quality Assurance or related areas in a GMP environment, including a position of authority in decision making and management of documentation and / or IT.
- Experience in leading training programs and projects in a GMP environment is preferred
- Basic knowledge in multiple quality processes and interfaces with multiple functional areas
- Knowledge of Good Manufacturing Practices standards, local and international regulatory requirements with regards to data integrity & quality culture
- Knowledge of Documentation and Electronic Systems that generate and manage GxP processes and Computer System Validation
- Excellent team spirit and communication skills
- Very good knowledge of French AND English (written and spoken)
Our offer?
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.
