(Senior) Quality Operations Officer - Ncardia - Gosselies
Ncardia
Région
Gosselies
Ncardia is an established, globally operating, stem cell-based drug discovery & cell therapy company. At Ncardia, we believe that stem technology will help get better therapies to patients faster. The company is a supportive and trusted partner for scientists operating within the human induced pluripotent stem cell (hiPSC) drug discovery and cell therapy fields, and in particular, in the cardiovascular and neurology space.
Ncardia develops, produces and commercializes hiPSC based solutions. Our offerings range from concept development to pre-clinical studies, including custom manufacturing of a range of cell types, as well as discovery services such as disease modelling, screening, and safety assays. Manufacturing process development expertise supports the development of cell therapy products.
We are an enthusiastic, skilled, and committed international team in which everyone has the opportunity to make a decisive contribution. Within our global QA team there is a position immediately available for a (Senior) Quality Operations Officer, who will report to the Chief Quality Officer.
Our internal culture statement promotes Ncardia as an ambitious company expecting from its employees a positive attitude, transparent behavior, respectful communication, with integrity as the most important value.
For more information about the company, please visit our website www.ncardia.com .
J ob Description
The Quality Operations Officer will hold responsibility for the QA operational activities within our global Quality Management System. Ncardia has an ISO9001 based Quality management system for its research cell products, that is currently being extended to the rest of the organization to support Ncardias business goals in drug discovery and cell therapy.
Tasks and Responsibilities include (but are not limited to):
Responsible for Document Control
Responsible for Training Registration
Responsible for Batch Review
Responsible as QA representative for non-conformaties, changes and CAPAs
Guides, trains, support the operational team with root cause analyses and defining corrective actions
Performs evaluations, GAP analyses and risk assessments
Performs internal audits
Advises on process improvements
Supports execution of site/team continuous improvement goals and projects
Providing training on implemented processes and guidelines
Support of QA Systems activities on a case by case basis
Required experience
BSc/MSc or equivalent working and thinking level in Life Sciences
5 years relevant work experience (e.g CRO or CDMO)
Vast experience with QA operational activities
Experience with Lean and Kaizen
Knowledge of ISO9001 or another Quality System
Knowledge of GxP, GAMP and/or APIs is/are a plus
Experience with GLP quality systems and/or ITIL is a plus
Required skills
Highly motivated, proactive, accurate, and committed team worker
We expect commitment and flexibility as well as reliability and open mindedness.
Demonstrated experience prioritizing conflicting demands in a fast-paced environment
Ability to deliver high quality documentation, paying attention to detail
Excellent verbal, written, and presentation skills with the ability to communicate clearly in English
Experience in working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems
Good communication skills and team-player
Good knowledge of Microsoft Office
Good knowledge of QMS/DMS application is a plus
Job Location:
Gosselies (BE)
Position type:
100%
Start Date :
Immediately
We offer a challenging position in a dynamic biotech company with room for personal growth and development. Depending on your education and experience, we provide an appropriate salary.
Interested?
For questions or further information about this vacancy, please contact Wendie Hamelink ([email protected]).
Send your motivation letter with curriculum vitae by October 16th to: [email protected]
Ncardia develops, produces and commercializes hiPSC based solutions. Our offerings range from concept development to pre-clinical studies, including custom manufacturing of a range of cell types, as well as discovery services such as disease modelling, screening, and safety assays. Manufacturing process development expertise supports the development of cell therapy products.
We are an enthusiastic, skilled, and committed international team in which everyone has the opportunity to make a decisive contribution. Within our global QA team there is a position immediately available for a (Senior) Quality Operations Officer, who will report to the Chief Quality Officer.
Our internal culture statement promotes Ncardia as an ambitious company expecting from its employees a positive attitude, transparent behavior, respectful communication, with integrity as the most important value.
For more information about the company, please visit our website www.ncardia.com .
J ob Description
The Quality Operations Officer will hold responsibility for the QA operational activities within our global Quality Management System. Ncardia has an ISO9001 based Quality management system for its research cell products, that is currently being extended to the rest of the organization to support Ncardias business goals in drug discovery and cell therapy.
Tasks and Responsibilities include (but are not limited to):
Responsible for Document Control
Responsible for Training Registration
Responsible for Batch Review
Responsible as QA representative for non-conformaties, changes and CAPAs
Guides, trains, support the operational team with root cause analyses and defining corrective actions
Performs evaluations, GAP analyses and risk assessments
Performs internal audits
Advises on process improvements
Supports execution of site/team continuous improvement goals and projects
Providing training on implemented processes and guidelines
Support of QA Systems activities on a case by case basis
Required experience
BSc/MSc or equivalent working and thinking level in Life Sciences
5 years relevant work experience (e.g CRO or CDMO)
Vast experience with QA operational activities
Experience with Lean and Kaizen
Knowledge of ISO9001 or another Quality System
Knowledge of GxP, GAMP and/or APIs is/are a plus
Experience with GLP quality systems and/or ITIL is a plus
Required skills
Highly motivated, proactive, accurate, and committed team worker
We expect commitment and flexibility as well as reliability and open mindedness.
Demonstrated experience prioritizing conflicting demands in a fast-paced environment
Ability to deliver high quality documentation, paying attention to detail
Excellent verbal, written, and presentation skills with the ability to communicate clearly in English
Experience in working with cross-functional teams and facilitating teams to identify and implement solutions to complex problems
Good communication skills and team-player
Good knowledge of Microsoft Office
Good knowledge of QMS/DMS application is a plus
Job Location:
Gosselies (BE)
Position type:
100%
Start Date :
Immediately
We offer a challenging position in a dynamic biotech company with room for personal growth and development. Depending on your education and experience, we provide an appropriate salary.
Interested?
For questions or further information about this vacancy, please contact Wendie Hamelink ([email protected]).
Send your motivation letter with curriculum vitae by October 16th to: [email protected]