QA Sterility Expert – Senior - Pharma sector
Brabant Wallon, Belgium
About Nalys
Nalys is a fast-growing consultancy company specialized in high-tech engineering and life sciences. We partner with leading organizations to deliver innovative solutions and expert support across a wide range of technical domains. At Nalys, we combine deep expertise with a human-centric approach — empowering our consultants to thrive and our clients to succeed. Joining Nalys means becoming part of a collaborative, agile, and forward-thinking team that values excellence, innovation, and continuous growth.
About the Role
We are looking for a
Sterility Expert – Senior
to join our partner, a global leader in the pharmaceutical industry. This role is critical for ensuring sterility assurance across aseptic processes and maintaining compliance with regulatory standards. You will act as the subject matter expert for sterility assurance topics, supporting operational teams and contributing to strategic initiatives in a dynamic environment.
Your Responsibilities
* Develop, implement, and oversee sterility assurance practices aligned with cGMP and regulatory guidelines
* Manage critical and complex deviations related to sterility assurance and lead CAPA processes
* Approve Environmental Monitoring Risk Assessments, SOPs, aseptic audits, and media simulation summaries
* Act as the SME during audits and inspections for aseptic topics; provide coaching and mentoring to QA and operational teams
* Support QMS gap analysis impacting sterility assurance and contribute to major technical interventions in classified areas
* Deliver aseptic training and develop competencies for sterility assurance on the shop floor
* Collaborate on projects aimed at improving aseptic practices and facility upgrades.
Skills & Qualifications
* You have a minimum 8 years of experience in sterility assurance or aseptic QA within the pharmaceutical industry.
* You have a strong expertise in aseptic practices/processes, material transfer, gowning, and environmental monitoring in classified areas
* In-depth knowledge of cGMP and international guidelines
* You have a proven experience in risk management and ability to influence and escalate sterility-related issues
* You are french speaker with a good command of English
* Operational excellence background (Lean Six Sigma Orange/Green Belt) is a plus.
Why Join Us?
* Work on strategic projects with high impact on global production standards.
* Be part of a collaborative team driving innovation in aseptic processes.
* Hybrid work model with flexibility.
Recruitment Process
At Nalys, our hiring process is designed to be transparent and engaging:
1. Olivia Braszko, TA Specialist at Nalys, will review your application and schedule an initial screening
2. A second interview will be held with one of our technical experts
3. Final interview with our Business Unit Director, Jimmy Rousseaux.