Qa Specialist

Details of the offer

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 RoleMajor accountabilities:Batch 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.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.Raise, 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 documentation.Self-inspections and supplier/third party assessments according to schedule.
Propose and monitor actions to improve/maintain quality standards.Provide QA/QC support for product launches.Deliver on KPI measures in a timely way.Day-to-day coordination and communication with external functions (e.g., distributors, analytical laboratory, customers).Perform product return evaluations and determine disposition.Handling of technical product complaints.Training to ensure continuous quality maintenance and quality improvement.Take responsibility for corporate citizenship within the sphere of influence and control, and to enforce the Company Code of Conduct.Key performance indicators:Adherence to cGMP and SOPs.Compliant product supply and business targets are met.No delay with new product launches caused by QA.Local GxP Quality systems in place and maintained.Quality related processes carried out in a timely way.GxP risks proactively identified and effectively mitigated.Training conducted according to program.Delivery of established KPI with regard to quality and performance.Timely close out of Deviations and corrective and preventative actions.Compliance with all aspects of the Code of Conduct/Corporate Citizenship/Novartis Policies and Procedures.Minimum Requirements:Experience in the pharmaceutical industry (quality assurance, quality control, registration, or production) or a directly related field will be beneficial.BPharm Degree.Registered with The South African Pharmacy Council.Skills:Knowledge and understanding of GMP, quality systems, and quality practices.Regulations & Guidelines.Document management.Analytical thinking and problem-solving.High compliance.Communication and interpersonal skills.
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Nominal Salary: To be agreed

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