Join a dynamic team at a leading Contract Manufacturing Organisation and contribute to groundbreaking projects and cutting-edge solutions.
Proclinical is seeking a Batch Record Reviewer to support Quality Assurance activities within a GMP-regulated environment. This role involves reviewing both electronic and paper-based batch records, identifying and investigating discrepancies, and ensuring strict adherence to GDP. The successful candidate will collaborate across multiple departments and utilize various systems to troubleshoot issues and uphold high standards of quality and compliance.
Please note that to be considered for this role you must have the right to work in this location or hold an EU passport.
Responsibilities:
- Review electronic and paper-based batch records for accuracy and completeness.
- Investigate discrepancies such as failed process parameters, material consumption issues, and operator comments using relevant systems and cross-departmental collaboration.
- Evaluate and clarify comments added to batch records, ensuring adherence to GDP and ALCOA principles.
- Collaborate with the Batch Record Review (BRR) team and other departments to resolve issues and provide quality impact statements.
- Utilize systems to investigate and address batch record concerns.
- Perform additional tasks, including authoring post-production lifecycle documents and compiling cleaning report data.
Key Skills and Requirements:
- A bachelor's degree or equivalent in a life science or biotechnological field is preferred.
- Experience working in a GMP-regulated environment is advantageous.
- Familiarity with production batch record review and quality assurance processes is highly beneficial.
- Ability to work independently and meet deliverables within target dates.
- Proficiency in English is required; German language skills, particularly reading, are a plus.
If you are having difficulty in applying or if you have any questions, please contact Ashley Bennett at a.bennett@proclinical.com.
If you are interested in applying to this exciting opportunity, then please click 'Apply' or to speak to one of our specialists please request a call back at the top of this page.
Proclinical is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Proclinical is acting as an Employment Agency in relation to this vacancy.
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