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QA Expert Quality System

Il y a 3 mois

Bruxelles, Région de Bruxelles, Belgique Mithra Pharmaceuticals SA Temps plein

Overview:

QA Expert Quality System & Compliance

Responsibilities:


Be the QA Expert Quality System & Compliance for Mithra Pharmaceuticals SA, Novalon SA, Estetra SRL, Neuralis SA and Mithra R&D SA.

Be responsible for maintaining and improving the QMS of Mithra Group.
Drive and maintain an appropriate level of compliance to Mithra Group QMS.
Drive and maintain an appropriate level of training to Mithra Group QMS.
Provide training to the teams on quality topics.
Participate in the writing, reviewing, approval of QMS documents: QM, POL, CSOP, WKI, FORM, Annexes.
Follow-up on KPIs for DEV, CAPA, RR and training for Mithra Group, and maintain oversight. Plan meetings as appropriate.
7 Ensure the management of DEV, CAPA, CC and RR within the area of expertise.

Set-up and maintain an effective system for the management of partners/ suppliers/ subcontractors/ CMO for

Mithra Group:
selection, risk-based assessment, audit, approval/ qualification, follow-up, periodic review/re-qualification. Ensure oversight.
Be the quality representative for CMO management.
Prepare, plan and facilitate Management Review Meetings of Mithra Group and related reports.
Ensure oversight of clients' audits and authorities' inspections for Mithra Group. Ensure inspection/audit readiness. Actively participate in audits/inspections. Participate in addressing audits/inspections' observations.
Edit Mithra Group's internal audit plan and ensure its oversight.
Ensure internal and external audits in the area of expertise.
Support the R&D activities with a quality mindset.
Ensure that critical issues are adequately and timely escalated.
Be involved in and support continuous improvement in the area of expertise.
Follow training as needed to fulfill function requirements.

Back-up of QA manager

Qualifications:

Scientific degree.

5-10 years of experience in pharma industry (ideally GDP, GCP, GVP, GLP).

French, English.

Constructive and solution-oriented mindset. Lean mindset.

Well organised and structured way of working, can work on several projects at the time.

Resistant to stress.

Is comfortable working alone or as part of a team.

Is comfortable with interdepartmental relations and projects.

Has the necessary authority to reach consensus and to move projects forward.