Senior QARA Specialist & Deputy Responsible Pharmacist at Baxter International Inc.

The Senior QARA Specialist is responsible:

To ensure that CQA processes are in place in his / her region:

• Local Complaint Coordinator activity
• Product Surveillance activity for Medicinal Products and Medical Devices
• Field Action execution

Supplier & Distributor Management:

• Implementation of Baxter Quality System in the region and audit management
• NCR, CAPA and Change Management
• Selling Authorizations and release of products according to local requirements
• Ensure back up persons for critical processes in the region are appropriately trained and back up are always available.
• To ensure that processes and procedure related to mentioned activities are compliant to local regulations, to the Corporate Quality Manual and to ISO 9001 and 13485 requirements.

To ensure that RA processes are in place in his / her region:

• To proactively monitor, review, interpret, and translate all national regulatory requirements of the Medicines Regulatory Authority
• To develop and implement strategies for earliest possible regulatory approvals to support business plans
• To maintain a good standing with the local regulators and to effectively manage the regulatory activities in line with the company expectations.
• To ensure appropriate contacts with country Supply Chain, Pharmacovigilance, TS, W&D and Businesses are maintained.

As the Deputy Responsible Pharmacist of Baxter entity in South Africa:

• To ensure company compliance with the Medicines and Related Substances Act and the Pharmacy Act and cGMP in the control of medicines and medical devices distributed and sold by Baxter Healthcare.
• To support the Quality activities of the Third-Party Logistics Warehouse in South Africa.