National Bioproducts Institute NPC has a vacancy for the role of Validation Officer. The successful incumbent will be required to:
\n\tTo ensure compliance with the NBI Validation Master Plan and cGMP requirements in all qualification and validation activities executed at NBI. This includes the writing of required validation protocols, execution of validation activities and compilation of validation reports. \u00a0In addition, to witness activities of third-party contractors and conduct training where required<\/p>\n
Minimum Requirements\u00a0\u00a0 \u00a0<\/p>\n
\tMatric
\n\tBachelor\u2019s degree or National Diploma in Chemical Engineering, Process Engineering, Biotechnology, Microbiology, Chemistry, or relevant science or engineering qualification.
\n\tA minimum of 2 years\u2019 experience in the pharmaceutical manufacturing environment or similar environment.
\n\tPrior experience in the qualification\/validation of process equipment, manufacturing processes, cleaning procedures, utilities and analytical methods would be advantageous<\/p>\n
Duties & Responsibilities\u00a0\u00a0 \u00a0
\nConduct Validation activities<\/p>\n
\tEngage with the validation team and form part of the validation team for all validation activities taking place at NBI.
\n\tLiaise with internal customers, equipment and process owners regarding requirements for qualifications and validation tasks to which they are assigned to.
\n\tWitness qualification\/validation\/calibrations conducted by third-party service providers.
\n\tEnsures that all validation activities are executed in a timely manner, following the approved protocols.
\n\tImmediately communicate discrepancies or deviations to protocols or expected outcomes to the internal stakeholders, \u00a0and ensure that they are investigated and resolved using the internal QMS process.
\n\tEnsure that record keeping and good documentation practices are maintained during the validation process.<\/p>\n
Compile Validation protocols<\/p>\n
\tCompile new validation protocols and update existing protocols based on the requirements of the user taking cGMP and latest guidelines into account for the methodology to conduct the validation activity.<\/p>\n
Compile Validation Reports<\/p>\n
\tCollect data, documentation and information required for the qualification or validation activity.
\n\tCollate and analyse the validation data obtained to identify possible anomalies from the expected result.
\n\tCompile technical reports and summaries for each of the qualification or validation activities that are conducted.<\/p>\n
Calibration programme<\/p>\n
\tEnsure that the instrument calibration schedule is adhered to.
\n\tEnsure that all assigned files and indexes for calibrations are kept up to date.<\/p>\n
Training<\/p>\n
\tCompile procedures where necessary and provide training of staff on relevant SOP\u2019s developed during validation.<\/p>\n
Ad hoc<\/p>\n
\tProvide support to all the NBI departments regarding validation requirements and issues.
\n\tAssist with QA related events and activities as and when required.
\n\tRepresent the validation team where required.<\/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-33774","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\/33774","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=33774"}],"wp:term":[{"taxonomy":"job_listing_region","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job_listing_region?post=33774"},{"taxonomy":"job_listing_type","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-types?post=33774"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}