Job Description Summary<\/p>\n
\tProvide quality assurance expertise, guidance and support to operational activities to ensure compliance with applicable regulatory requirements and Novartis procedures and quality standards.<\/p>\n
Job Description<\/p>\n
Major accountabilities: <\/p>\n
\tBatch record review and related activities (e.g., PIT, reference standards ordering and management, import permit application, method transfer, sample and temperature checks) for timely market release of finished goods.
\n\tProduct Quality Reviews according to schedule, in order to monitor the quality of products and compliance against the marketing authorization.\u00a0 Compile PQR reports for product renewals.
\n\tArtwork review
\n\tRaise, investigate, manage and actively resolve quality investigations as needed e.g., deviations, complaints, CAPAs, non-conformances in conjunction with third parties and operational units to minimize impact on product availability and business.
\n\tCreate and maintain GxP documentation
\n\tSelf-inspections and supplier \/ third party assessments according to schedule. Propose and monitor actions to improve\/maintain quality standards
\n\tProvide QA\/QC support for product launches.
\n\tDeliver on KPI measures in a timely way
\n\tDay-to-day coordination and communication with external functions (e.g distributors, analytical laboratory, customers)
\n\tManage goods for destruction
\n\tPerform product return evaluations and determine disposition
\n\tHandling of technical product complaints.
\n\tTraining to ensure continuous quality maintenance and quality improvement
\n\tTake responsibility for corporate citizenship within the sphere of influence and control, and to enforce the Company Code of Conduct<\/p>\n
Key performance indicators: <\/p>\n
\tAdherence to cGMP and SOPs
\n\tCompliant product supply and business targets are met
\n\tNo delay with new product launches caused by QA
\n\tLocal GxP Quality systems in place and maintained
\n\tQuality related processes carried out in a timely way
\n\tGxP risks proactively identified and effectively mitigated
\n\tTraining conducted according to program
\n\tDelivery of established KPI with regard to quality and performance
\n\tTimely close out of Deviations and corrective and preventative actions
\n\tCompliance with all aspects of the Code of Conduct\/ Corporate Citizenship\/ Novartis Policies and Procedures<\/p>\n
Minimum Requirements:
\nWork Experience: <\/p>\n
\tExperience in the pharmaceutical industry (quality assurance, quality control, registration or production) or a directly related field will be beneficial
\n\tQualified Pharmacist registered with the South African Pharmacy Council.<\/p>\n
Skills: <\/p>\n
\tKnowledge and understanding of GMP, quality systems and quality practices
\n\tRegulations & Guidelines
\n\tDocument management
\n\tAnalytical thinking and problem solving
\n\tPlanning & organizing
\n\tHigh compliance
\n\tCommunication and interpersonal skills.
\n\tContinuous Learning
\n\tSelf Awareness<\/p>\n
Languages :<\/p>\n
\tEnglish.<\/p>\n
Apply via company website ( http:\/\/www.novartis.com ) or<\/p>\n
novartis.wd3.myworkdayjobs.com<\/p>\n
<\/p>\n","protected":false},"author":2,"featured_media":0,"template":"","meta":{"_promoted":"","_job_location":"","_application":"http:\/\/novartis.wd3.myworkdayjobs.com","_company_name":"Novartis","_company_website":"http:\/\/www.novartis.com","_company_tagline":"Novartis provides healthcare solutions that improve and extend people\u2019s lives. We use science-based innovation to address some of society\u2019s most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible. Our com... read morepany is focused on industry-leading divisions with innovation power and global scale: pharmaceuticals, eye care and generic medicines Novartis is headquartered in Basel, Switzerland. Novartis Group companies employ approximately 120,000 associates and its products are available in more than 180 countries around the world. Novartis South Africa (Pty) Ltd 72 Steel Road Spartan ZA- Kempton Park, Gauteng 1619 South Africa","_company_twitter":"","_company_video":"","_filled":0,"_featured":0,"_remote_position":0,"_job_salary":"","_job_salary_currency":"","_job_salary_unit":""},"job_listing_region":[11],"job-types":[12],"class_list":["post-17374","job_listing","type-job_listing","status-expired","hentry","job_listing_region-gauteng","job-type-full-time"],"jetpack_sharing_enabled":true,"_links":{"self":[{"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-listings\/17374","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=17374"}],"wp:term":[{"taxonomy":"job_listing_region","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job_listing_region?post=17374"},{"taxonomy":"job_listing_type","embeddable":true,"href":"https:\/\/jobs.dataaxisnode.com\/southafrica\/wp-json\/wp\/v2\/job-types?post=17374"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}