Reference Number: JO-2310-525120
QA Batch Release Officer
Job Type: Permanent
Location: Elstree, Borehamwood
We are looking for a QA Batch Release Officer to join a Pharmaceutical Manufacturing company based out of Hertfordshire.
1. To be primary QA contact for batch release and document review.
2. Participate in daily updates for batch release priority.
3. Review and understand deviations and changes related to batch review and be able to assess them on behalf of the QP.
4. Complete GMP reviews of batch documents.
5. Highlight significant GMP and patient safety concerns to supervisor or QP’ as needed.
6. Complete batch review monitoring as required with any local spreadsheets or logs.
7. Complete transactions or updates in systems that support batch review such as LIMS, IFS and TrackWise.
8. To participate as required in Regulatory and customer audits.
9. To undertake work related to job objectives as directed by QA management.
10. Raising Events for errors and non-conformances in batch documentation
11. Conducting live reviews in the processing areas
12. Gain an understanding and knowledge of the process flow applicable to batch documentation reviewed (when required liaise with SME)
13. Prepare and generate Certificates of Analysis for sale of intermediates.
14. Provide intermediate assessment and release for further processing.
– Degree level qualification in science discipline or equivalent.
Skills and Experience
– 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.
– Experience with blood products is desirable but not essential.