Job Advert Summary\u00a0\u00a0 \u00a0<\/p>\n
\tGuided by its purpose to provide products for patients to alleviate pain and suffering and improve their quality of life, NBI\u2019s vision is to be the leading African manufacturer and supplier of quality therapeutic proteins and diagnostic products.
\n\tNational Bioproducts Institute NPC has a vacancy for the role of a Active Raw Material(ARM) Quality Manager. The successful incumbent will be responsible for:
\n\tContributing to the quality, safety, and efficacy of NBI\u2019s products through:
\n\tRigorous evaluation and approval of new plasma suppliers in line with NBI specifications and local and international guidelines, and
\n\tReview of epidemiological data and other data from plasma suppliers and updating of NBI\u2019s plasma master file on an annual basis, and
\n\tTesting and release of human plasma and its derivatives (active raw materials) procured from plasma suppliers, adhering to sound scientific principles and complying with current good manufacturing practice (cGMP).
\n\tFurther, the Plasma Quality manager is responsible for the smooth, efficient day to day operation of the Quality Active Raw Material (QARM) laboratory, providing operational assurance in support of business and strategic requirements. Lastly, the Plasma Quality manager is responsible for NBI\u2019s formal environmental monitoring program, through monitoring production environments, including NBI\u2019s aseptic filling suite, to ensure the environments comply with regulations.
\n\tApplications are invited from suitably qualified and experienced candidates.<\/p>\n
Minimum Requirements<\/p>\n
\tM.Sc in Microbiological Science, Molecular Biology, Biochemistry or related field (PhD degree preferred)
\n\tComputer literacy: MS Office, SAP, LIMS
\n\t5 to 10 years as a senior staff manager in a quality or pharmaceutical environment
\n\tAt least 5 years of Quality Control or Microbiology laboratory experience
\n\tWorking knowledge of GMP in blood establishments, transfusion transmittable infections, plasma quality and safety, as well as related regulatory requirements preferred.
\n\tThorough understanding of cGMP, GLP and international pharmaceutical standards preferred.
\n\tHands-on experience with internal and supplier audits will be an advantage.<\/p>\n
Duties & Responsibilities\u00a0\u00a0 \u00a0<\/p>\n
\tEnsuring on-going safety and quality of plasma and its derivatives through compliance to NBI\u2019s specifications
\n\tKeep abreast of new and emerging developments\/changes in guidelines on the production, control and regulations of human plasma derived medicinal products.
\n\tKeep appraised of national and international trends and regulatory standards.
\n\tReview and maintain specifications for plasma in accordance with the European Pharmacopoeia monograph and NBI Plasma specifications.
\n\tParticipate in appropriate industry forums, congresses and meetings on viral safety, GMP in blood establishments and plasma fractionation in low and middle income countries.
\n\tCommunicate to plasma and intermediate suppliers all criteria set out in NBI specifications to ensure suppliers meet NBI\u2019s requirements.
\n\tMaintain strong relationships with plasma suppliers and other external stakeholders to ensure plasma quality standards are achieved.
\n\tReview of new and existing plasma suppliers and updating of the plasma master file (PMF)
\n\tAssess potential plasma suppliers for producing high quality plasma suitable for fractionation and ensuring compliance with GMP in blood establishments. These include verification that suppliers adhere to GMP standards and relevant regulatory requirements.
\n\tAudit new and existing plasma suppliers to ensure their compliance to safety, quality, GMP, NBI\u2019s requirements.
\n\tEvaluate collection, testing, storage and transportation of plasma from suppliers
\n\tCommunicate plasma quality and safety problems\/issues to suppliers.
\n\tResearch information and analyse annually, the possible risk of virus and other transmissible agents by NBI plasma products using documented risk models.
\n\tCollate epidemiological data and other data from the donor population to continuously survey prevalence, incidence and trends of infectious or quality markers relevant to the safety and quality of NBI\u2019s medicinal products and propose counter measures.
\n\tPromote support for the implementation of new testing regimes.
\n\tCompile Plasma Master File annual updates for submission to SAHPRA to obtain approval for plasma suppliers under a contract fractionation agreement or to other regulatory bodies for plasma suppliers that are under a toll fractionation agreement.
\n\tAssist with any queries by SAHPRA on new plasma suppliers and the plasma master file.
\n\tQARM laboratory management
\n\tPlan and coordinate plasma, intermediate and final product testing based on formal specifications and production needs.
\n\tManage QARM laboratory staff for timely analysis and reporting of active raw materials.
\n\tPropose and implement effective strategies for the optimal testing and processing of plasma and its derivatives
\n\tEnsure prompt release of raw materials and intermediate products for production.
\n\tManage the construction and testing of plasma pools
\n\tEnsure test kit providers are approved by SAHPRA and testing is performed in accordance to NBI\u2019s regulatory product dossiers.\u00a0
\n\tCollaborate closely with Plasma Stores to identify reconciliation challenges and develop solutions to address them
\n\tManage non-compliant plasma between NBI Plasma Stores and QARM
\n\tManage lookbacks systems at NBI
\n\tImplement and maintain an external proficiency testing program.
\n\tMaintain in-house controls and reference standards.
\n\tSAP and LIMS
\n\tEnsure all SAP and LIMS transactions are completed as required for the release of active raw materials, and intermediates.
\n\tPerform SAP tasks as required by the quality management system and other business processes.
\n\tEnsure LIMS and SAP is optimally set up and utilised to support effective, productive and efficient QARM laboratory operations, and identify opportunities for further improvement to maximise LIMS functionality.
\n\tAnalytical methods and laboratory equipment
\n\tAssess the feasibility and benefits of new analytical methods, preparing justifications and CAPEX requests.
\n\tDevelop user requirement specifications for new QARM facilities, equipment, and contract testing.
\n\tAssist the Validation Team in preparing IQ, OQ, and PQ documents for qualification.
\n\tCoordinate equipment qualifications and method validations, providing necessary documents to Regulatory Affairs for SAHPRA submissions.
\n\tOversee the implementation of new analytical methods and equipment post-SAHPRA approval, following NBI\u2019s change management procedures.
\n\tMaintain a program for calibrating, servicing, and maintaining analytical equipment to ensure accuracy and prevent breakdowns.
\n\tManagement of external \/ contract laboratories
\n\tCoordinate with outsourced laboratories to ensure testing, results are completed within NBI\u2019s timelines and any changes to testing is reported to NBI immediately
\n\tEnsure contract laboratories use suitable and validated analytical methods.
\n\tAudit relevant contract laboratories per as NBI\u2019s vendor management program, to ensure that test procedures are in line with NBI\u2019s requirements.
\n\tReview relevant external testing service agreements.
\n\tManage and oversee NBI\u2019s environmental monitoring program
\n\tDefine NBI\u2019s environmental monitoring and contamination control strategy to comply with the relevant guidelines such as PIC\/s Annex 1.
\n\tDraft, review, approve and implement SOP\u2019s and other controlled documents related to environmental monitoring.
\n\tDefine critical control points for environmental monitoring and sampling sites based on risk assessments.
\n\tDefine action and alert limits of the various microbiological sample areas (Grades A to D, raw materials, intermediates and final products).
\n\tEnsure adequate resources are available for sampling, testing, and the oversight of the aseptic filling processes by the Production Microbiologists and Microbiology Technician and that the Aseptic Filling room is released prior final product filling
\n\tPerform trend analysis of bioburden results and environmental results to allow for corrective actions to be implemented promptly.
\n\tAssist with compiling reports and the evaluation of aseptic process simulations.
\n\tPerform investigations and identify root causes in case of sterility failures and other Microbiological data deviations, viral contamination, aseptic process simulations and related risk assessments to products.
\n\tReview and reporting of trends
\n\tMonitor, analyse and report on trends of key QARM performance indicators as part of monthly, quarterly and annual reviews and reports, including annual product quality reviews, or APQRs.
\n\tCoordinate with applicable QARM laboratory staff to ensure the monthly review of reference standards and inhouse controls is performed, including statistical analysis and reporting of the trends.
\n\tEnsure the appropriate use of sound statistical analysis of results.
\n\tPrepare quarterly and annual reports on analytical results of raw materials, in-process and final product testing, as well as utilities.
\n\tAttend quarterly and annual review meetings and provide input into the meetings as required.<\/p>\n
go to method of application \u00bb<\/p>\n
Apply via company website ( N \/ A ) or<\/p>\n
<\/p>\n","protected":false},"author":2,"featured_media":0,"template":"","meta":{"_promoted":"","_job_location":"","_application":"","_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-23241","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\/23241","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=23241"}],"wp:term":[{"taxonomy":"job_listing_region","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job_listing_region?post=23241"},{"taxonomy":"job_listing_type","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-types?post=23241"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}