QA Qualification/Validation & EM 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 Qualification/Validation & EM 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 Qualification/Validation & Environmental monitoring, ensure quality oversight of the Qualification/Validation & Environmental monitoring project activities.

• Be the quality representative for Qualification/Validation & Environmental monitoring, ensure quality oversight of the Qualification/Validation & Environmental monitoring project activities, participate in key meetings and decision steps for Qualification/Validation & Environmental monitoring projects
• Review and approve documentation related to qualification/validation of production equipment: qualification/validation strategies, qualification protocols and reports, risk assessments, …
• Review and approve documentation related to Environmental monitoring
• Support, review and approve POL/SOP/WKI write-up for related activities
• 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
• Escalate any quality risks / issues to higher QA management
• Actively participate in continuous improvement of plant activities
• Participate in internal audit program and CAPA follow-up
• 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 10 years experienced in QA Qualification/Validation
• Bachelor or Master in a Scientific Area
• Good knowledge of GMP
• Good knowledge in English
• 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-QQV-022021

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