Batch record reviewer

Proclinical is seeking a Batch Record Review and Support Specialist. The successful candidate will focus on reviewing executed electronic batch records and supporting quality assurance processes. This position requires attention to detail and effective communication with various teams to ensure compliance and facilitate timely product release.

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 executed electronic batch records, including cleaning logs, production documentation, temperature reports, and more.
• Clarify and evaluate comments on batch records with the operations team and QA Manager.
• Initiate and support the resolution of deviations and investigations related to batch record observations.
• Assist in the initiation of Change Requests (CRs) and Temporary Change Requests (TCRs).
• Prepare documentation packages for quick release by QA.

Key Skills and Requirements:

• Familiarity with GDP and GMP regulations in the pharmaceutical or API industry is beneficial.
• Ability to identify non-compliance and quality standard gaps.
• Excellent communication skills and ability to interact with various organizational interfaces; strong team player.
• Structured, focused, and organized work approach.
• Open to new ideas and solutions; solution-oriented mindset.
• Agile, motivated, and dynamic.
• Capable of producing reliable results under pressure.
• Knowledge of MES Syncade and DeltaV systems is preferred.
• Fluent in English; basic knowledge of German is advantageous.

If you are having difficulty in applying or if you have any questions, please contact Emile De Beer at e.debeer@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.