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DIVISION CMM DEPARTMENT Quality Assurance EMPLOYMENT TYPE Permanent JOB PURPOSE The QA Inspector is responsible for daily quality oversight of manufacturing and packaging activity on the shop floor in accordance with cGMP and company SOPs. Their core role is to optimally support production and related functions while maintaining acceptable quality standards to meet business requirements. ACCOUNTABILITIES Report immediately any significant deviation observed during work activity to the QA Pharmacist/Responsible Pharmacist and Department Manager. Conduct online in-process checks for production lines as per requirements Follow Health, Safety and Environment policy of the organization Carry out QA line clearance verification of manufacturing cubicles, packaging lines and dispensing booths during product change over or after a major clean prior to production start-up. Carry out proof checking of packaging components authorizing packaging to use the components during the line opening, line closing and if there is roll changes, lot changes or if additional material is requested. Verification of material returns/restraint from production to returning to stores. Verification of rejected material and associated documentation sign off. Online investigation of manufacturing and packaging related problems to help eliminate deviations and to verify compliance to product/ in process specification. Check assay calculations during dispensing. Assist with filling of all finished product retention samples in accordance with relevant SOPs. Logging of finished product at QC lab for packed product analysis and logging of customer samples with QA release administrator. To be competent in using instruments used to perform IPC tests. Sampling and analysis of suspect or potentially suspect products in line with the relevant SOPs (AQL Inspection). Reviewing updated BMR's, BPR's, and rework and trial protocols. Verifying of part case quantity and signing part case before line closing. Preparation of test solution in IPC lab where required. Calibration of instrument in the IPC lab. Qualification of new instrumentation in the IPQA lab, including drawing up qualification of protocols for qualification. Online rejection of non-conforming product or material. Follow Personnel Hygiene practices and monitor Departmental hygiene. Ensure cleanliness, maintenance of department, premises and equipment Ensure Raw material, packing material, intermediate products and finished goods are stored appropriately (With respect to designated area, identification of labels, and storage conditions). Verify environmental conditions of all areas are maintained as per requirement. Monitoring of shop-floor (Manufacturing/Packing/Stores/QC) activities and review of related documents. Involvement in investigation of non-conformances as applicable. Involvement in investigating customer complaints as applicable. Drawing up of new SOPs and updating of written procedures (SOP) in the IPC laboratory as applicable when due for revision. To monitor and ensure that appropriate entries in the logbooks (Cleaning Log, Machine Logs, Temperature and Humidity logs, etc.,) of the respective areas are filled by the respective users of the user departments. Verifying of reconciliation and stock transfer sheet after every batch end of the packed stock (packaging). Perform additional related duties as assigned by supervisor and manager. Labelling of finished product for release after normal office hours (after 16H30)/when required. Issuing of additional BMR/BPR pages as per production requirements after normal office hours (after 16H30)/when required. Verification of date of mixing for manufacturing and expiry date for packing after normal office hours (after 16H30)/when required. Sampling of process validation batches when required. EDUCATIONAL QUALIFICATION Matric /Grade 12 with Math's and Science - Science is essential Tertiary qualification (Diploma/Degree) Pharmacist Assistant (Basic/Post Basic) - an added advantage RELEVANT EXPERIENCE Experience in Solids/Pharmaceutical/Manufacturing environment an advantage Computer literate JOB LOCATION Mobeni SHIFT 06: 00- 14:00 14:00- 22:00 22:00- 06:00 Apply Now

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