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QA Batch Release Officer

Location
Borehamwood, Hertfordshire
Job Type
Contract
Posted
17 Sep 2022
International Pharmaceutical Manufacturer seeks an experienced QA Batch Release Officer to work on a 12-month Fixed Term Contract. About the role: 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. Raising Events for errors and non-conformances in batch documentation Skills and experience: Degree level qualification in science discipline or equivalent. Experience of working within a (bio) pharmaceutical, clean room or manufacturing environment. Knowledge of sterile aseptic filling and packing manufacturing processes is desirable. The job holder is expected to demonstrate a willingness to engage in self-directed learning, an ability to assimilate new information into their routine working practices and a desire to develop their level of experience and expertise. Experience of working with documentation and quality management systems desirable. A natural tendency towards continuous improvement is required
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Details

  • Job Reference: 714701478-2
  • Date Posted: 17 September 2022
  • Recruiter: Marketplace Technical
    Marketplace Technical
  • Location: Borehamwood, Hertfordshire
  • Salary: On Application
  • Sector: Healthcare & Medical
  • Job Type: Contract