Job Description

Summary 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) 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 review
• 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
• Qualified Pharmacist 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

Languages :

• English.

Why Novartis:
Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here:
You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
Novartis South Africa is committed to promoting equity (race, gender, and disability) through the filling of this post with a candidate whose transfer/promotion/appointment will promote representivity in line with the numerical targets as contained in our Employment Equity plan. While we are prioritizing designated groups, our selection process will still be based on the most suitable candidate, with the necessary skills and experience, as outlined in the job description.
Skills Desired Agility, Audit Management, Business Partnering, Change Control, Continued Learning, Health Authorities, Influencing Skills, Knowledge Of Capa, Qa (Quality Assurance), Quality Management, Quality Management Systems (QMS), Risk Management, Root Cause Analysis (RCA), Self-Awareness, Sop (Standard Operating Procedure), Technological Expertise