QA Technical Writer
About this role
Planet Pharma
POSITION SUMMARY
Reporting to the Manager Compliance, the Compliance Specialist is responsible for creating, managing, and maintaining technical documentation for our cell and gene therapy manufacturing site. This includes writing, editing, and reviewing documents such as quality systems (deviations, change controls and capas). The ideal candidate will be a critical thinker with experience in biotechnology or pharmaceuticals, excellent writing skills, and ready to apply specialized skills in technical writing, compliance, data analysis…etc..in a regulated environment.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Generate and leading the facilitation in the completion of quality system documents for the manufacturing site (Deviations, CAPAs, Change Controls, etc)
- Ensure all documentation is clear, concise, and adheres to company standards and regulatory guidelines
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