Commercial Quality Specialist

R per month Monthly Basic Salary (Market related)

The Commercial Quality Specialist is responsible for performing Quality Assurance activities in the Commercial Quality Department. The CQ Specialist will also be responsible for compliance with the elements of the Johnson & Johnson Quality Policy and J&J QMS that are applicable to the GMP/GDP activities the LOC / Cluster undertakes. This position is also responsible for the continuous improvement of the GMP / GDP status of the LOC / Cluster, including the oversight of quality and compliance status of all third parties and other J&J organizations engaged by the LOC / Cluster for the GMP / GDP activities for the LOC/ Cluster.

Implement, maintain, and monitor the GMP/GDP part of the J&J quality system for commercial organization in the LOC / Cluster.

• Responsible for the Release of Finished product
• Process all QA Complaints
• Control Substance Management
• Deviations - Initiate Quality Investigations
• Change Control - Initiate Change Controls.
• Prepare QSMR report and presentation, detailing key activities and metrics in the QA department as per SOP
• Annual Product Review
• Audit Management
• QA Project/Activities
• Back up support for all other QA functions for Quality Assurance department
• Compliance Matters
• Third Party Logistic (3PL) /Distributors/ Third Party Manufacturers (3PM)
• Post Importation Testing
• Escalation of Quality and Regulatory Compliance Issues

Minimum requirements, candidate must be a qualified pharmacist registered with South African Pharmacy Council with 1-2 years' experience in Quality Assurance.

• B. Pharm/ Pharmacy Degree
• Minimum 2 years' experience in Quality Assurance, Production, Distribution or Pharmaceutical Industry

1. Up-to-date knowledge of relevant local pharmaceutical legislation and GMP/GDP/GLP
2. Strong analytical, communication, decision-making and leadership skills for interaction with external and internal customers and partners
3. Knowledge and full understanding of Quality Management System Policy (POL-001), the Commercial Quality standard operating procedures and the Quality Manual