Job Summary:
We are seeking a QA Specialist Automation, EBR and Batch Record Review (f/m/d) to join our Vibe-X QA Operations team. This role will be responsible for ensuring the buildup and execution of cGMP compliant manufacturing and documentation processes in Vibe-X.
About the Role
The successful candidate will partner with internal customers to ensure quality topics are addressed during the setup of Electronic Batch Records (eBR) in the Vibe-X project.
* Checking and approval of master production records and electronic master batch records (EMBR); ensuring consistency with approval documents, process descriptions, transfer documents, test plans, parameter lists, etc.
* Review of executed batch records within defined timelines.
* Review of minor deviations, investigations, and CAPAs within defined due dates.
* Ensuring batch records are closed and archived when all batch-related activities are completed.
* Contributing to the management and tracking of Key Performance Indicator (KPI) and Quality metrics; supporting the QA department for internal and external meetings (batch tracker meetings, deviation review board, IPT, etc.).
Requirements
To be successful in this role, you will need:
* Bachelor or Master of Science in chemistry, biotechnology, life sciences, or another related field.
* Experience in the GMP-regulated pharmaceutical/API industry.
* Ability to recognize non-compliance and gaps in quality standards.
* A structured, precise, and well-organized work attitude; open-minded to new ideas and suggestions; agile, highly motivated, and dynamic.
Preference will be given to candidates who have worked with electronic batch records (execution and/or review).