QA Specialist

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

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)Qualification: B. PharmQualified Pharmacist registered with the South African Pharmacy CouncilSkills: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.