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Sterility Assurance Senior

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Amaris Consulting

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Location:
Belgium , Wavre

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Category:
Manufacturing

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Contract Type:
Not provided

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Salary:

Not provided
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Job Responsibility:

  • Own the MU’s sterility assurance risk profile, including the transversal strategy to mitigate/remediate risks and continuous improvement of the Sterility Assurance Quality System
  • Develop, implement, and maintain a comprehensive sterility assurance program/roadmap, including accountability for the MU’s Contamination Control Strategy
  • Monitor and improve manufacturing processes to identify potential sources of contamination and drive CAPA
  • Interpret microbiological data and trends, provide holistic recommendations, and drive implementation of process improvements
  • Perform analyses related to the performance of the area of expertise
  • Proactively monitor and oversee MU performance related to sterility assurance, including shopfloor Gemba walks
  • Drive MU compliance to GMP and QMS requirements for sterility assurance
  • Contribute to sterility assurance knowledge management and coordination across the site/network
  • Ensure compliance with local and international standards, cGMP, regulatory requirements, and internal QMS policies and procedures, as well as adherence to EHS rules
  • Act as front-room representative during regulatory and corporate inspections and internal audits
  • Participate in the design and review of CAPEX projects impacting sterility assurance
  • Manage Change Controls related to sterility assurance initiatives
  • Share and integrate best practices within the site and the wider company network
  • Maintain up-to-date expertise in sterility assurance, microbiology, aseptic manufacturing, and quality management
  • Identify MU needs and provide coaching/training in the area of expertise
  • Ensure proactive benchmarking across MUs, site SMEs, and local/global departments.

Requirements:

  • Bachelor's degree in Sciences or equivalent experience
  • At least 5 years of professional experience in a pharmaceutical manufacturing environment producing sterile drugs or vaccines
  • Strong understanding of regulatory requirements, including cGMP and relevant international guidelines
  • Strong sterility assurance and microbiology background
  • Ability to balance GMP requirements with manufacturing reality
  • Strong analytical, problem-solving, and root cause analysis skills
  • Continuous improvement mindset
  • Excellent interpersonal and communication skills
  • Proven influencing skills
  • Training and mentoring capabilities
  • Strong quality and results-oriented mindset
  • Very good level of French and English, spoken and written
  • Preferred specializations: Microbiology (strong plus), Agronomy, Pharmacy, Biology, Biochemical Engineering
  • Preferred: Master's degree in Sciences or equivalent experience
  • Lean / Six Sigma knowledge is an advantage (e.g. Green Belt certification).

Nice to have:

  • Lean / Six Sigma knowledge is an advantage (e.g. Green Belt certification)
  • Preferred specializations: Microbiology, Agronomy, Pharmacy, Biology, Biochemical Engineering
  • Preferred: Master's degree in Sciences.
What we offer:
  • Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees
  • Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions
  • International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.

Additional Information:

Job Posted:
May 04, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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