Reference: CPT000390-CH-1 The QA Manager and Deputy Responsible Pharmacist will manage, maintain and enhance the the South Africa Quality Management System to be SAHPRA inspection-ready at all times and assume all the batches released to market. Quality Management Processes: Manage all final product manufacturers (local Manufacturing Licenses and Site Master Files in place. Manage the local GMP Audit program and conduct external these are maintained as per revision register. Manage the Change Control process and facilitate and capture
business support. Provide regular feedback to the RA Manager and cross functional team and marketing teams on of delay emerge. Proactively identify issues and manage risk, taking appropriate action as required on License maintenance e.g., Renewals Pharmacovigilance e.g., LRMP Labelling and Artwork Management Robust Robust Health Authority interactions To track and manage all GRP activities and report any non-compliances business priorities. License maintenance: Ensure all post-approval product maintenance activities including CMC
and Objective Responsible for the regulatory management of South Africa and some Southern African markets the company. Primary Responsibilities Direct management of part of the portfolio for South Africa and communication/clarity of regulatory strategy and timelines. Manage the performance of direct reports, (where applicable) Regulatory Science/CMC, Supply Chain, Submissions Management, other Viatris Country Offices, Labelling teams liaising with Regulatory Science/CMC, Submissions Management, Cluster/Markets, and other key stakeholders
Reference: CPT000390-CH-1 The QA Manager and Deputy Responsible Pharmacist will manage, maintain and enhance the the South Africa Quality Management System to be SAHPRA inspection-ready at all times and assume all the batches released to market. Quality Management Processes: Manage all final product manufacturers (local Manufacturing Licenses and Site Master Files in place. Manage the local GMP Audit program and conduct external these are maintained as per revision register. Manage the Change Control process and facilitate and capture
Assist on artwork and related projects Implement and manage a Pharmacoviligance system compliant to local health shortcomings to stakeholders and in the correct format. Manage all Final product manufacturers, Final Release Quality/Technical agreements are in place for all our products Manage and facilitate artwork projects with the different dossier and legislation. Manage and maintain the relevant artwork master files. Manage bar codes and nappi COA's are in line with the products specifications Manage and role out stability programs per product, per
Assist on artwork and related projects Implement and manage a Pharmacoviligance system compliant to local health shortcomings to stakeholders and in the correct format. Manage all Final product manufacturers, Final Release Quality/Technical agreements are in place for all our products Manage and facilitate artwork projects with the different dossier and legislation. Manage and maintain the relevant artwork master files. Manage bar codes and nappi COA's are in line with the products specifications Manage and role out stability programs per product, per