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QA CSV & IT Expert (m/f)

Vous êtes ici : Accueil1 / Carrières2 / QA CSV & IT Expert (m/f)

QA CSV and IT Expert (m/f)

Company

Mithra (Euronext: MITRA) is a Belgian biotech company dedicated to transforming Women’s Health by offering new choices through innovation, with a particular focus on contraception and menopause. Mithra’s goal is to develop products offering better efficacy, safety and convenience, meeting women’s needs throughout their life span. Its three lead development candidates are built on Mithra’s unique native estrogen platform, Estetrol (E4): Estelle®, a new era in oral contraception, PeriNesta®, the first complete oral treatment targeting perimenopause and Donesta®, the next-generation hormone therapy. Mithra also develops and manufactures complex therapeutics in the areas of contraception, menopause and hormone-dependent cancers. It offers partners a complete spectrum of research, development and specialist manufacturing at its technological platform Mithra CDMO.

Active in more than 100 countries around the world, Mithra has an approximate headcount of 300 staff members and is headquartered in Liège, Belgium

Description

Mithra is looking for an QA CSV&IT Expert to join its QA System department to work at Mithra CDMO, its R&D and Manufacturing platform located in Flémalle.

Mission

Be the quality representative for the CSV&IT project team, ensure quality oversight of the CSV&IT project activities.

Duties and responsibilities

  • Be the quality representative for the CSV&IT project team, ensure quality oversight of the CSV&IT project activities, participate in key meetings and decision steps for CSV&IT projects
  • Ensure compliance with CSV&IT regulation
  • Support CSV&IT projects for impact assessment, programming, testing, implementation, documentation, maintenance
  • Review and approve qualification/validation documentation related to CSV&IT projects (including serialization)
  • Support, review and approve POL/SOP/WKI write-up related to CSV&IT activities
  • Manage suppliers/subcontractors related to CSV&IT projects: selection, risk assessment, qualification, periodic requalification
  • Ensure quality system application, maintenance and periodic review (deviation, CAPA, risk, change control, documentation …)
  • Take part, review, support and approve investigations related to deviations and CAPAs with a solution driven perspective
  • Ensure that critical topics are adequately and timely escalated to higher QA management
  • Actively participate in continuous improvement of plant activities
  • Ensure inspection/audit readiness. Actively participate in inspection/audit by authorities and customers
  • Follow training as needed to fulfill function requirements
  • Provide training for the team on quality topics

Profile

  • Minimum 5 years experienced in QA CSV&IT
  • Good knowledge of cGMP
  • Good knowledge in :
    • Root Cause Analysis of deviations and risks-based approach;
    • Validation methodology and application of cGMP from complex systems (ERP, LIMS, e-QMS, …) to laboratory equipmentRegulations such as GAMP 5, Eudralex Volume 4 – annexe 11 et 21 CFR part 11 in pharmaceutical industry
    • Qualification of IT Infrastructure
  • Good knowledge in English
  • Office Tools
  • Agility by working in various environments (Production, QC, IT, …)
  • Communication and knowledge sharing
  • Able to work independently and within a team
  • Resourceful, Assertif and stress resistant

What we offer

Varied and motivating responsibilities within a fast growing company.
An attractive salary package in line with your experience.

Application

Send your CV and application letter to: belgium.job@mithra.com.
Your email must mention following subject: CDMO-QCSV-022021

Recruitment Agencies, please refrain from contacting us or sending us CVs on a spontaneous

 

Mithra Pharmaceuticals

Rue Saint-Georges 5
4000 Liège
Belgium

Tel. : +32 (0)4 349 28 22
Fax : +32 (0)4 349 28 21
Email : info@mithra.com

Euronext

Awards

European Rising Tech

European Business AwardEuropean Business Award
l'Entreprise de l'année 2015


essenscia
Randstad


BelMid euronext

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