Junior QA RA Specialist

Overview

As 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 Junior 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 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 the 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 ThirdParty Logistics Warehouse in South Africa.
  
  

Requirements

• Qualification 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 Pharmacist
  
• Ability to liaise 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 Afrikaans
  
• Must have a valid drivers licence and own vehicle;
  
• Must be willing to travel locally and internationally;
  
• Must have a valid passport.
  
• Stress resistance and able to work in a rapid response environment
  
• Excellent communication 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
  
• Selfmotivated with a high level of initiative
  
• Detail Oriented
  
• Continuous Learner
  
• Collaborative
  
• Critical Thinker
  
• Influential
  
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