QA Specialist at Novartis

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) 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)
• Manage goods for destruction
• 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:
Work Experience:

• 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
• Planning & organizing
• High compliance
• Communication and interpersonal skills.
• Continuous Learning
• Self Awareness