Batch Record Review and Support Specialist

Proclinical is collaborating with a biotechnology company who are seeking a Batch Record Review and Support Specialist. In this role, you will focus on ensuring the accuracy and compliance of batch records within a dynamic biotechnology environment. This position is crucial for maintaining high-quality standards and supporting the release of products.

Please note that to be considered for this role you must have the right to work in this location.

Responsibilities:

• Review executed electronic Batch Records, including cleaning logs, production documentation, temperature reports, test procedures, autoclave and washing machine protocols, used material, calibration records, sample results, and logbooks.
• Address and clarify comments added to executed Batch Records with the operations team and evaluate with the responsible QA Manager.
• Initiate and support the resolution of deviations and investigations related to Batch Record review observations.
• Assist in the initiation of Change Requests (CRs) and Temporary Change Requests (TCRs).
• Support the preparation of documentation packages to enable fast release by QA.

Key Skills and Requirements:

• Experience in GDP and GMP regulated pharmaceutical or API industry is advantageous.
• Ability to identify non-compliance and gaps from quality standards.
• Excellent communication skills and ability to interact with various interfaces within the organization; strong team orientation.
• Structured, focused, and well-organized working attitude.
• Open-minded and solution-oriented.
• Agile, highly motivated, and dynamic.
• Ability to produce reliable results under stress.
• Knowledge of MES Syncade and DeltaV systems is preferred.
• Fluent in English; basic knowledge of German is an advantage.

If you are having difficulty in applying or if you have any questions, please contact Ashley Bennett at a.bennett@proclinical.com.

Apply Now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, 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.