Quality Assurance Consultant

Job content

Global Quality Specialist
Brabant Wallon - Contracting

Our partner is looking for a Global Quality Specialist to reinforce its teams and assist with delivery of the risk-based audit program by acting as the central point of contact for the audit management tool and offering expert support for inputs (associated with Audits and Inspections), outputs (for the Pharmacovigilance System Master File when applicable), and overall general support to the Quality Auditing & Compliance team on data and processes across the regulated GxP environment.
Your responsibilities?

Acts as main point of contact in Quality Auditing & Compliance team for the audit management tool.
Makes extractions from the audit management tool for data inclusion within internal reports as well as to meet Health Authority requirements
Develops, prepares and improve KPIs/metrics on performance.
Support the development and maintenance of training matrix for Quality Auditing & Compliance team.
Support the maintenance of Quality Auditing & Compliance team’s controlled documents.
Support the execution of the audit Risk Assessment by contributing to data collection and maintenance.
Performs quality control checks on extracts from audit management tool for associate initiatives (e.g. PV Compliance Dashboard, audit and inspection data report).
Maintains listings of global health authority inspections for the purpose of renewals.
Supports the execution of the risk based audit programs through ensuring audit program listings are up to date.
Maintains the departmental mailbox.
Participates as required to the weekly audit scheduling meeting.
Supports the GxP QMS/eQMS audit process harmonization and maintenance across Quality Auditing & Compliance team.
Supports auditors with auditing and inspection activities from technologies and digitalization perspective.
Develops and/or updates processes associated with main responsibilities.
Participates in projects within competence.
Upon the request of/with the approval of the Head of Quality Auditing & Compliance CoE

Your profile?

Bachelor/Master in Life Science, Computer Science Degree.
3 years’ experience in the pharmaceutical/biotechnology area and/or Quality-related areas.
Experience in the pharmaceutical industry within regulated areas (e.g., Research, Laboratory, Clinical, Pharmacovigilance, Manufacturing, …) and/or Quality Assurance expertise is a plus.
Experience with Cognos, Veeva Systems, and/or Sparta’s TrackWise is preferred.
Fluent in computerized systems ; making extractions from systems to prepare listings and metrics. Experience with data migrations is preferred.
Familiarity with GxP systems in the pharmaceutical industry and of applicable regulations, computerized system validation, GXP principles, and practice. Able to apply theoretical knowledge in practical situations.
Familiarity with statistical principles, quality principles and data integrity principles.
Familiarity with Drug Substance and/or Drug Product manufacturing production processes and related Quality Systems.
Mind-set to understand Compliance and Regulatory issues.
Fluent in written and spoken English

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.