About the position
Commercial Quality Specialist:
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.
KEY RESPONSIBILITIES:
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.
Required Qualification and Core Competencies for the role:
Essential knowledge and skills:
- B. Pharm/ Pharmacy Degree
- Minimum 2 years’ experience in Quality Assurance, Production, Distribution or Pharmaceutical Industry
Core competencies required for this role:
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
Desired Skills:
- attention to detail
- deadline driven
- focused
- energetic
