Website Novartis
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 com… read morepany 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. Novartis South Africa (Pty) Ltd 72 Steel Road Spartan ZA- Kempton Park, Gauteng 1619 South Africa
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.
Job Description
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.
Apply via company website ( http://www.novartis.com ) or
novartis.wd3.myworkdayjobs.com