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Quality Systems EtO Sterilization & Validation Expert
The international Medical Device company operating from Leuven, Belgium, provides supporting services in quality systems, quality assurance and quality control to internal and external customers on an EMEA basis. As part of this department, the QS Validation Expert ensures the quality oversight of the process validation activities. Main responsibility is to ensure EtO sterilisation validation and process validation activities comply with the applicable European and FDA regulations, guidelines and Global Quality Policies.
Maintain the Process validation and EtO Sterilisation validation process in
- Maintain the QMS procedures on process validation of EtO sterilization and manufacturing processes, including risk management process (process FMEA) to be compliant with applicable European and FDA regulations, guidelines and Global Quality Policies.
- Supervise the EtO sterilization validation engineer and train the process validation engineers.
- Maintain and follow-up the VMP’s and periodic reviews to ensure the processes are timely re-validated.
- Review and approve EtO sterilization validation files for compliance with EN ISO 11135.
- Coach QA engineers in the review process of process validation files and monitor this review process.
- Follow-up EtO Sterilisation validation subcontractor.
- Responsible for non-conformity handling related to process and sterilisation validation issues (including audit non conformities): investigate CAPA need, guide investigation to the root cause of the non-conformity and review corrective actions proposed. Ensure proper documentation and follow-up implementation of corrective actions, effectiveness evaluations for CAPA and closure of the non-conformity.
Execute and support quality systems audits
- Participate in the internal audits.
- Support regulatory, corporate and customer audits as subject matter expert for process and sterilization validation, supported by the validation engineers.
Skills and personality
- University or technical degree in engineering, scientific, medical or pharmaceutical oriented education, or equivalent by experience.
- Expert in the technical domain of EtO sterilisation validation and process validation. Profound knowledge of EN ISO 11135, EN ISO 13485, 21 CFR Part 820, GHTF/SG3/N99-10.
- Minimum 5 years professional experience in medical and/or pharmaceutical environment.
- Good working knowledge of English (written and spoken).
- Team player with strong communication skills to collaborate with different partners across the organization.
minimum 5 years
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