Sterility Assurance Officer
Walloon Brabant
Life Sciences - QA
Work experience: 5-7
Reference number: 92194
- Senior QA specialist responsible for sterility assurance in aseptic manufacturing
- Ensures compliance with GMP, regulatory requirements, and industry standards
- Acts as local Subject Matter Expert (SME) for Sterility Assurance
Key Responsibilities
- Manage critical sterility-related deviations (Grade A/B, hidden surfaces) and associated CAPAs
- Approve Environmental Monitoring Risk Assessments and aseptic documentation
- Act as SME for sterility assurance topics across manufacturing units
- Approve and support SOPs related to aseptic processes
- Lead and support aseptic audits and inspections
- Approve media simulation (aseptic process simulation) summaries
- Perform or co-approve QMS gap analyses impacting sterility assurance
- Coach and mentor QA and operational teams; deliver aseptic and sterility training
- Serve as audit/inspection lead for aseptic topics
- Support major technical interventions in classified areas (e.g. shutdowns)
What are we looking for?
Profile & Experience
- University degree in Science, Engineering, Quality, Manufacturing, or Bioengineering
- Preferred: MSc, MEng, Pharmacist, or Bioengineer
- Minimum 5–8 years’ experience in a GMP-regulated sterile manufacturing environment
- Strong expertise in aseptic processes, environmental monitoring, gowning, and material transfer
- Solid knowledge of cGMP and regulatory guidelines (FDA, EU, WHO)
- Strong risk management, decision-making, and influencing skills
- Operational Excellence certification (Orange/Green Belt) is a plus
- Fluent French with good professional English
What do we offer?
- Enjoy a competitive salary package with extra perks that recognize your talent.
- Advance your career with a clear growth path, coaching, and mentoring to support you.
- Thrive in a dynamic and supportive environment where you can truly make an impact.
- Work when and where you perform best, ensuring an optimal work-life balance.
- Choose a flexible transport solution, from a company car to a public transport subscription.
- Expand your network and enjoy unforgettable moments at exclusive events and afterworks.
- Grow your skills with external courses and our in-house Pauwels Academy.
- Work on exciting projects with industry leaders in Life Sciences, Engineering & Digital.
- Seize opportunities at every level, from a strong start to career acceleration and expert collaboration.
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