QA Operations Raw material specialist
vor 1 Tag
Hiring Manager: Diem Nouvene
Recruiter: Kata Kulcsar
Location: Aubonne | Zone Industrielle de L'Ouriettaz
Department: HC-GM-QFUIB QA Release Raw Materials
Grade: Expert 1
Your role:
- INCOMING MATERIAL RELEASE
- Raw materials release management:
- To perform the release of raw materials according to approved specifications and continuously improve the process and update SOPs related to material release.
- To perform the review and approval of materials specifications or update of materials specifications.
- To manage deviations, CAPA and CCP related to material release.
- Suppliers and materials:
- To manage and evaluate Change Notifications related to material release in collaboration with SQM.
- CLEAN UTILITIES RELEASE
- To manage the release of clean Utilities in collaboration with QC, TDO, QA Engineering and Manufacturing: coordinate activities related to the release (validation of analytical results, manage the deviation related to the release, perform the follow-up of related CCP and trends) and lead the Water/Gas committee.
- To collaborate under improvement projects (Pipeline Pilot) for Clean Utilities Release to digitalize the release reports in collaboration with Global functions.
Your profile:
- Chemistry, biology, microbiology or pharmacy master degree with minimum 3 years of experience in Pharmaceutical industry.
- Experience in Quality Assurance, Quality Assurance operation or Quality Control is a plus.
- Expertise in cGMP best practices.
- Experience in Utilities is a plus.
- Good knowledge on laboratory equipment and software (like SAP, Glims, Trackwise…) is a plus.
- Fluent in French and English.
- Having a team spirit and being collaborative and curious are essential.
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