Manufacturing Batch Reviewer I / Associate Manufacturing...

at  RoslinCT

QUALIFICATIONS

• A BSc in a Life Science subject or other equivalent laboratory experience.
• For the Manufacturing Batch Reviewer I level position, in addition to all the above, we would expect a minimum 1 years’ experience in Sterile Manufacture- and/or Quality-related role.

• An exciting opportunity to join our team as an Associate Manufacturing Batch Reviewer / Manufacturing Batch Reviewer I. The level of the role will be dependant on experience.
• Review executed manufacturing batch documentation (batch records, in-process data and environmental monitoring data) to ensure GMP compliance and adherence to operational SOPs.
• Using a “right first time” approach, assure all comments and annotations are clear and concise.
• Provide regular feedback on findings during document audit to relevant departments as appropriate.
• Assure timely communication of quality events identified during document audit with relevant departments, including raising deviations.
• Input batch-related data into Manufacturing and QA batch review trackers where applicable.
• Work to ensure timely closure of packs for batch disposition and shipment to patient by working collaboratively with relevant departments.
• Support with daily OQIT housekeeping activities, including but not limited to filing, photocopying and transferring documents to other RoslinCT sites.
• Attend OQIT meetings to provide appropriate feedback in respect status and progression of manufacturing documentation.
• Assist in training and coaching relevant personnel to develop their GMP recording, review and technical writing skills.
• Accountable for maintaining a clean, orderly and safe work environment and adhere to set safety standards.
• For the Manufacturing Batch Reviewer I level position, we also expect:
• Attendance at OQIT meetings to provide appropriate feedback in respect status and progression of manufacturing documentation.
• Assist in training and coaching relevant personnel to develop their GMP recording, review and technical writing skills.