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QA Specialist

Novartis AG

  • East Hanover, NJ
  • 4 days ago

    Highlights

    Training to ensure continuous quality maintenance and quality improvementTake responsibility for corporate citizenship within the sphere of influence and control, and to enforce the Company Code of ConductKey Performance Indicators:Adherence to cGMP and SOPsCompliant product supply and business targets are metNo delay with new product launches caused by QALocal GxP Quality systems in place and maintainedQuality related processes carried out in a timely wayGxP risks proactively identified and effectively mitigatedTraining conducted according to programDelivery of established KPI with regard to quality and performanceTimely close out of Deviations and corrective and preventative actionsCompliance with all aspects of the Code of Conduct/ Novartis Policies and ProceduresMinimum Requirements: Work Experience:Minimum 3 years experience in the pharmaceutical industry (quality assurance, quality control, registration or production)Skills:Knowledge and understanding of GMP, quality systems and quality practicesRegulations & GuidelinesDocument managementAnalytical thinking and problem solvingPlanning & organizingHigh complianceCommunication and interpersonal skills. Deliver on KPI measures in a timely wayDay-to-day coordination and communication with external functions (e.g distributors, analytical laboratory, customers)Manage goods for destructionPerform product return evaluations and determine dispositionHandling of technical product complaints.

    Numbers & Facts

    LocationEast Hanover, NJ
    IndustryBiotechnology/Pharmaceuticals
    Company Size10,000 employees or more
    Year Founded1996

    Description

    Job ID

    REQ-10085133

    Aug 11, 2026

    South Africa

    Available in: English

    Summary

    Provide quality assurance expertise, guidance and support to operational activities to ensure compliance with applicable regulatory requirements and Novartis procedures and quality standards.

    About the Role

    Major Accountabilities:Batch record review and related activities (e.g., PIT, reference standards ordering and management, import permit application, method transfer, sample and temperature checks, PITE) for timely market release of finished goods.Product Quality Reviews according to schedule, in order to monitor the quality of products and compliance against the marketing authorization. Compile PQR reports for product renewals.Artwork reviewRaise, 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.Create and maintain GxP documentationSelf-inspections and supplier / third party assessments according to schedule. Propose and monitor actions to improve/maintain quality standardsProvide QA/QC support for product launches.Deliver on KPI measures in a timely wayDay-to-day coordination and communication with external functions (e.g distributors, analytical laboratory, customers)Manage goods for destructionPerform product return evaluations and determine dispositionHandling of technical product complaints.Training to ensure continuous quality maintenance and quality improvementTake responsibility for corporate citizenship within the sphere of influence and control, and to enforce the Company Code of ConductKey Performance Indicators:Adherence to cGMP and SOPsCompliant product supply and business targets are metNo delay with new product launches caused by QALocal GxP Quality systems in place and maintainedQuality related processes carried out in a timely wayGxP risks proactively identified and effectively mitigatedTraining conducted according to programDelivery of established KPI with regard to quality and performanceTimely close out of Deviations and corrective and preventative actionsCompliance with all aspects of the Code of Conduct/ Novartis Policies and ProceduresMinimum Requirements: Work Experience:Minimum 3 years experience in the pharmaceutical industry (quality assurance, quality control, registration or production)Skills:Knowledge and understanding of GMP, quality systems and quality practicesRegulations & GuidelinesDocument managementAnalytical thinking and problem solvingPlanning & organizingHigh complianceCommunication and interpersonal skills.Continuous LearningSelf AwarenessLanguages :English.

    Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-cultureBenefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally.Read our handbook (PDF 30 MB)

    Division

    Operations

    Business Unit

    Quality

    Location

    South Africa

    Site

    Midrand

    Company / Legal Entity

    ZA01 (FCRS = ZA001) Novartis SA (Pty) Ltd.

    Functional Area

    Quality

    Job Type

    Full time

    Employment Type

    Regular

    Shift Work

    No

    Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-cultureBenefits and Rewards: Learn about all the ways we'll help you thrive personally and professionally.Read our handbook (PDF 30 MB)

    Quality Operations South Africa

    Job ID

    REQ-10085133

    QA Specialist

    Apply to Job

    Job ID

    REQ-10085133

    QA Specialist

    Apply to Job

    About Company

    Novartis provides healthcare solutions that improve and extend people’s lives. We use science-based innovation to address some of society’s most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible. Our company 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.

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