Batch Release Officer

Marketplace Technical
04 Apr 2018
25 Apr 2018
Contract Type
Full Time

International Pharmaceutical Manufacturer requires a Batch Release Officer To review manufacturing batch records in preparation for QP disposition, ensuring batch records are complete, collated and ready for QP disposition.To work with manufacturing to correct batch record errors and as necessary review deviations related to batch release, to collate reviewed batch records as required and work with the QP’s to support batch disposition decisions, and to participate in organising and prioritizing the batch release process.

·Reviewing Batch Paperwork on a daily basis

·Address any problem which arises from Batch Release - liaise with QC and ILP

·A very good understanding of GMP is required from a Pharma background

·Someone from a Bioscience background

Duties to include:

1)To be primary QA contact for batch release and document review.

2)Participate in daily updates for batch release priority.

4)Review and understand deviations and changes related to batch review and be able to assess them on behalf of the QP

5)Complete GMP reviews of batch documents

6) Highlight significant GMP and patient safety concerns to supervisor or QP’ as needed.

7)Complete batch review monitoring as required with any local spreadsheets or logs.

8)Complete transactions or updates in systems that support batch review such as LIMS, IFS and TrackWise

9)To participate as required in Regulatory and customer audits.

10)To undertake work related to job objectives as directed by QA management.

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