QA Batch Release Officer

Recruiter
Adepto Technical Recruitment Limited
Location
Borehamwood
Posted
16 May 2018
Closes
15 Jun 2018
Contract Type
Permanent
Hours
Full Time
QA Batch Release Officer - Permanent - Biopharma - North London
Our client is a leading Biopharma organisation based in the UK. At present they are seeking x2 QA Batch Release Officers on a permanent basis at their idyllic site in North London. Applicants will ideally be degree qualified in a related science subject and will have previous batch release experience within a QA function.
Responsibilities:•To review manufacturing batch records in preparation for QP disposition.•Ensure 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.•Collate reviewed batch records as required and work with the QP’s to support batch disposition decisions.•Participate in organizing and prioritizing the batch release process.•To be primary QA contact for batch release and document review.•Participate in daily updates for batch release priority.•Review and understand deviations and changes related to batch review and be able to assess them on behalf of the QP•Complete GMP reviews of batch documents•Highlight significant GMP and patient safety concerns to supervisor or QP’ as needed.•Complete batch review monitoring as required with any local spreadsheets or logs.•Complete transactions or updates in systems that support batch review such as LIMS, IFS and TrackWise•To participate as required in Regulatory and customer audits.•To undertake work related to job objectives as directed by QA management.
This job was originally posted as www.totaljobs.com/job/81446813

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