Position: Responsible Pharmacist - QA and RA Specialist Medical IndustryJob Description OverviewAs a member of the Company's Quality team, you will play an essential part in the company's mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything they do, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people's lives.The Senior QARA Specialist is responsible:To ensure that Compliance QA 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 Quality System in the region and audit management NCR, CAPA andChange ManagementSelling 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 company 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 the company To support the Quality activities of the Third-Party Logistics Warehouse in South Africa.RequirementsQualification – BPharm necessary At least 3 years professional experience is required in the Quality and Regulatory fields.At least 2 years of experience is required as Responsible PharmacistAbility toliaise with internal and external stakeholders:Pharmacovigilance, W&D, Supply Chain, Compliance, Technical Services, Business, Regulatory Authorities, Third Party partners Good Knowledge of GMP; GDP; ISO 9001 and ISO 13485 Fluent in English and AfrikaansMust havea valid drivers licence and own vehicle;Must bewilling to travel locally and internationally;Must havea valid passport. Stress resistance and able to work in a rapid response environment Excellentcommunication skills, both verbal and written. Good organizational skills and the ability to multitask. Strong listening skills. Strong team player, with flexible approach yet able to work unsupervised and under pressure Self-motivated with a high level of initiative Detail Oriented Continuous LearnerCollaborativeCritical Thinker InfluentialRequirementsQualification – BPharm necessary At least 3 years professional experience is required in the Quality and Regulatory fields. At least 2 years of experience is required as Responsible PharmacistAbility toliaise with internal and external stakeholders:Pharmacovigilance, W&D, Supply Chain, Compliance, Technical Services, Business, Regulatory Authorities, Third Party partners Good Knowledge of GMP; GDP; ISO 9001 and ISO 13485 Fluent in English and AfrikaansMust havea valid drivers licence and own vehicle;Must bewilling to travel locally and internationally;Must havea valid passport. Stress resistance and able to work in a rapid response environment Excellentcommunication skills, both verbal and written. Good organizational skills and the ability to multitask. Strong listening skills. Strong team player, with flexible approach yet able to work unsupervised and under pressure Self-motivated with a high level of initiative Detail Oriented Continuous LearnerCollaborativeCritical Thinker Influential
