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Job Responsibility:
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.
Requirements:
Responsible for QA and RA communications with health authorities
Will be the nominated pharmacist in charge for Baxter's operating establishment
Will be the authorized signatory entity & official responsible pharmacist for all PVQARA communications
Will be nominated as Baxter's point of contact for all RA & QA activities in front of MOH
Assume the tasks of the Responsible Pharmacist of Baxter entity in Algeria as defined by the local regulations
Ensure company compliance with applicable Acts and regulations, and cGMP, in the control of medicines and medical devices distributed and sold by Baxter Healthcare
Prepare for MOH audits and ensure satisfactory outcomes
To keep awareness and being updated on relevant national Algerian and assigned countries’ legislation and inform ECEMEA cluster head and global teams about any relevant changes to the legislation
To ensure that CQA processes are in place in his / her region
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.