
Validation Documentation Specialist
hace 2 días
**Job Description**
Lumiere Systems is seeking a highly skilled Validation Documentation Specialist to join our team. This role will be responsible for managing document trackers, creating FAT & SAT documentation, and supporting the execution of IQ, OQ & PQ testing.
The ideal candidate will have strong written and verbal communication skills, as well as experience in technical writing and validation processes. They will also have knowledge of industry standards like ISO 9001, FDA regulations, and GxP guidelines.
Responsibilities:
- Manage document trackers and ensure timely review and approval of documents
- Create FAT & SAT documentation, including protocols and test plans
- Support the execution of IQ, OQ & PQ testing, including creating and maintaining test documentation and logs
- Work with technical teams to understand and document requirements and support validation efforts
Required Skills and Qualifications:
- Strong written and verbal communication skills
- Experience in technical writing and validation processes
- Knowledge of industry standards like ISO 9001, FDA regulations, and GxP guidelines
- Ability to work in a team environment and deliver on team objectives
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