Step into a pivotal role at a global CMO and help shape the future of healthcare manufacturing.
Proclinical is seeking a meticulous and detail-oriented Batch Record Reviewer to ensure that manufacturing batches are completed accurately and in compliance with regulatory and procedural standards. This position requires strong attention to detail, the ability to work independently, and a solid understanding of manufacturing processes. Proficiency in German is essential for this role.
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:
- Analyse and evaluate electronic batch records within allocated timeframes.
- Oversee, report, and observe batch record reviews and other critical metrics to ensure timely batch release.
- Identify and document deviations promptly, support investigations, and assist in defining corrective and preventive actions (CAPAs).
- Participate in documentation updates and electronic batch record change requests.
Key Skills and Requirements:
- Proven working history in a GMP production environment, including quality procedures and SOP execution.
- Academic background in Pharmaceutical Technology, Biotechnology, Chemistry, Pharmacy, or a related scientific field, or equivalent professional experience.
- Experience in electronic batch record review is highly preferred.
- Familiarity with systems such as Trackwise, SAP, and MES is advantageous.
- Strong communication skills and the ability to work effectively in a team.
- Business fluency in German is required; proficiency in English is preferred.
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.
By submitting this application, you confirm that you've read and understood our privacy policy, which informs you how we process and safeguard your data - https://www.proclinical.com/privacy-policy.
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