- To ensure that CQA processes are in place in his / her region:Local Complaint Coordinator activityProduct Surveillance activity for Medicinal Products and Medical DevicesField Action executionSupplier & Distributor Management:Implementation of Baxter Quality System in the region and audit managementNCR, CAPA and Change ManagementSelling Authorizations and release of products according to local requirementsEnsure 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 AuthorityTo develop and implement strategies for earliest possible regulatory approvals to support business plansTo 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.
- 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.
Senior QARA Specialist - Johannesburg, South Africa - Baxter
Description
Vantive: A New Company Built On Our Legacy
Baxter is on a journey to separate our ~$5B Kidney Care segment into a standalone company. Vantive* will build on our nearly 70-year legacy in acute therapies and home and in-center dialysis to provide best-in-class care to the people we serve. We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us.
At Vantive, you will become part of a community of people who are focused, courageous and don't settle for the mediocre. Each of us are driven to help improve patients' lives worldwide. Join us as we revolutionize kidney care and other vital organ support.
*Completion of the proposed separation of Kidney Care from Baxter into a standalone company (to be named Vantive) remains subject to the satisfaction of customary conditions.
The Senior QARA Specialist is responsible:
As the Deputy Responsible Pharmacist of Baxter entity in South Africa: