Senior QARA Specialist & Deputy Responsible Pharmacist - Johannesburg
Baxter
This is where you save and sustain lives At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare. Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. Join us at the intersection of saving and sustaining lives-where your purpose accelerates our mission. 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. Reasonable Accommodations Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTAbaxter.com and let us know the nature of your request along with your contact information. Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice. 118570
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