QA CSV & IT Expert (m/f)

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

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.

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

• 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

• 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

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

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

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