̽»¨ºÏ¼¯

̽»¨ºÏ¼¯ 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.

̽»¨ºÏ¼¯ is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. ̽»¨ºÏ¼¯ is acting as an Employment Agency in relation to this vacancy.