National Bioproducts Institute NPC has a vacancy for the role of Production Administrator. The successful incumbent will be required to:<\/p>\n
\tTo manage and control the inflow, outflow and maintenance of all controlled documents required in the department.
\n\tTo maintain department stats, compile reports and perform the required SAP transactions to ensure the efficient operation of the department.
\n\tTo ensure administrative support to department staff and all stakeholders within the organisation
\n\tTo ensure statistics required by stakeholders are available
\n\tTo ensure stock availability by placing requisitions and follow through until received
\n\tTo track and report batch status to ensure facilitation of operations
\n\tCompilation of batch documentation for pharmacist review
\n\tAuditing of batch documentation for Pharmacist review
\n\tConfirmation and Goods Receipt of product yields on SAP for Pharmacist verification<\/p>\n
Applications are invited from suitably qualified and experienced candidates.<\/p>\n
Minimum Requirements\u00a0\u00a0 \u00a0<\/p>\n
\tRelevant Tertiary Qualifications
\n\tExposure to SAP or other Electronic control systems
\n\tProficiency in Microsoft Word and Excel
\n\t2 years\u2019 experience in a similar role within the pharmaceutical environment, with a firm understanding of cGMP and GDP<\/p>\n
Duties & Responsibilities\u00a0\u00a0 \u00a0
\nControl of MCDs<\/p>\n
\tVerification of MCD\u2019s and collection from QA.
\n\tEnsure correct filing of MCDs as per status of the batch in a timeous manner
\n\tCompilation and review of MCDs to ensure completion
\n\tConfirmation and Goods Receipt of product yields on SAP for Pharmacist verification
\n\tPre-audit of MCD as per checklist prior to pharmacist audit.
\n\tCheck that all calculations and formulations in the document are correct before pharmacist audit
\n\tSubmission of MCDs to ORP following pharmacist audit. Compilation of the final batch document to include all the reports and results of QC testing.
\n\tRecording status of MCDs in log books when submitted to ORP. Ensure MCDs are received and acknowledgement of receipt completed on log book. Management of the Document Tracing Register for accuracy to ensure traceability
\n\tRecording\/tracking of MCD status until submission to ORP
\n\tIn-process monitoring of the batch documentation to ensure that all mandatory information is completed and verified.
\n\tFollow up on MCD status for any queries where necessary
\n\tAction all document queries to the relevant pharmacists, section heads and technicians
\n\tAttend to MCD queries where possible.
\n\tMaintain document release target of two weeks from production to ORP.
\n\tCompilation of in-process data controls for product investigations<\/p>\n
Control of departmental SOPs<\/p>\n
\tMaintenance of departmental SOPs by ensuring that SOP files and indexes are kept up to date with current versions at all times
\n\tAssist in compilation of department MCD\u2019s, PCD\u2019s and SOP\u2019s for implementation
\n\tAssist with training of SOP\u2019s and uploading of training records on SAP DMS
\n\tControl of authorised copies of master document SOPs required for reference at the work stations
\n\tAudit departmental document files periodically and maintain and manage the document system.
\n\tMonitor status of documents under review periodically and follow up with relevant production personnel for completion of tasks
\n\tPre-audit of batch documents upon collection from QA and sign for accepting responsibility that the correct documents are ready for production<\/p>\n
Control of departmental log books<\/p>\n
\tControl of all departmental log books and registers
\n\tCompilation of departmental log books.
\n\tAudit completed logbooks and submit to QA for archiving
\n\tRequest new log books in a timeous manner and ensure log books are available for use on time<\/p>\n
Control of batch related information records<\/p>\n
\tGeneration of equipment\/machine reports and charts
\n\tPre-Auditing of batch reports and charts for accuracy
\n\tPrinting of reports and charts
\n\tAttachment of reports and charts to the correct documents.
\n\tRecording of batch information on reports and charts
\n\tEnsure reports and charts are approved and authorised by pharmacist prior to attachment to relevant MCD
\n\tMonitor status of documents under review periodically and follow up with relevant production personnel for completion of tasks<\/p>\n
Data capturing and compilation of reports Monitor the assigned departmental stock requirements and levels.<\/p>\n
\tUpdate of daily departmental statistics in a timeous manner
\n\tCompilation and Submission of the Monthly and Quarterly Process Control Review reports
\n\tCompilation of in-process data controls for product investigations
\n\tHighlighting and escalating discrepancies and trends observed
\n\tGeneration and printing of required reports from SAP
\n\tCompilation of Employee Overtime Reports
\n\tAssist in closing of departmental Notifications by printing SAP reports , to ensure that all outstanding notifications have been completed
\n\tAssisting with updating the skills matrix template<\/p>\n
Inventory management and procurement services<\/p>\n
\tMonitor the assigned departmental stock requirements and levels.
\n\tManage department stock takes to ensure reconciliation of stock
\n\tConduct weekly on-hand stock verification against SAP to ensure that the department stocks are up to date prior to periodic stock takes
\n\tCreate requisitions and reservations on SAP to order all departmental stock in a timeous manner.
\n\tTracking of all departmental non-stock items through procurement to ensure timeous receipt
\n\tFollow up with warehouse and procurement personnel regarding status of requisitions placed<\/p>\n
Plant maintenance co-ordination and admin support<\/p>\n
\tProcess plant maintenance notifications on SAP and liaise with Engineering Services.
\n\tAttend the weekly Compliance Meetings with QA to ensure South African Health Products Regulatory Authority (SAHPRA) Compliance
\n\tAssist in closing of GMP Audit and compliance findings and following up with relevant production personnel to action.
\n\tEnsure that departmental plant maintenance requests are processed and completed on time.
\n\tGenerate periodic reports to establish the status of departmental PM requests.Reports any identified risks, hazards and incidents<\/p>\n
Management of batch product labels<\/p>\n
\tEnsure expiry labels are requested in a timeous manner
\n\tEnsure that Goods Issue labels and GI Slips are signed by the pharmacist and attached to the correct batch documents
\n\tEnsure that Goods Receipt labels are signed by the pharmacist and available for attachment to the correct products with the correct information on the label
\n\tPrinting of all sample labels in a timeous manner
\n\tVerification for correctness of labels and availability when required.
\n\tPerform correct confirmations and goods receipt for the product yields manufactured to ensure that the correct labels are printed and that SAP reflects the correct quantities for product formulations<\/p>\n
Employee time and attendance<\/p>\n
\tDaily monitoring of time keeping of all employees in the department.
\n\tMaintenance of the Employee Overtime Template to track number of hours.
\n\tSubmit monthly report of Employee Overtime to the department Manager
\n\tPrinting of leave forms for the employees
\n\tCollection and distribution of employee payslips and related personal documents<\/p>\n
General administration<\/p>\n
\tResponsible for the general administration system within the department to ensure continual compliance with documented processes, procedures and cGMP.
\n\tCoordination of documents sent to Document Warehouse for archiving and ensure that records are kept for traceability and easily retrievable for audits.
\n\tTakes minutes of department meetings and distribute them timeously.
\n\tSupport in organising training, training rooms and training materials as required by the department.
\n\tAssist with departments participation in company events to uphold the reputation of the department
\n\tParticipate in the continuous improvement and development in the department.
\n\tLiaison with other departments
\n\tPerform ad-hoc secretarial duties for department section heads and manager<\/p>\n
Apply via company website ( N \/ A ) or<\/p>\n
nbisa.erecruit.co<\/p>\n
<\/p>\n","protected":false},"author":2,"featured_media":0,"template":"","meta":{"_promoted":"","_job_location":"","_application":"http:\/\/nbisa.erecruit.co","_company_name":"National Bioproducts Institute","_company_website":"http:\/\/N%20\/%20A","_company_tagline":"NBI is a private, non-profit, pharmaceutical manufacturer of human plasma-derived medicinal products. NBI's core business is to manufacture pharmaceutical products from human plasma, using a process of cold ethanol fractionation. NBI strives to meet the needs of patients and improve their quality of... read more life by providing protein therapies and services within the South and Sub-Saharan African region and diagnostic products globally.","_company_twitter":"","_company_video":"","_filled":0,"_featured":0,"_remote_position":0,"_job_salary":"","_job_salary_currency":"","_job_salary_unit":""},"job_listing_region":[16],"job-types":[12],"class_list":["post-32067","job_listing","type-job_listing","status-expired","hentry","job_listing_region-kwazulu-natal","job-type-full-time"],"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-listings\/32067","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-listings"}],"about":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/types\/job_listing"}],"author":[{"embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/users\/2"}],"wp:attachment":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/media?parent=32067"}],"wp:term":[{"taxonomy":"job_listing_region","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job_listing_region?post=32067"},{"taxonomy":"job_listing_type","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-types?post=32067"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}