Pharma QA Specialist - CAPA, Risk & Root Cause Expert

SciStaff CC; Durban; On-site; ZAR 200 000 - 300 000; Full time

Job summary

A leading pharmaceutical company in Durban is seeking a Quality Assurance Specialist to manage a formal CAPA program and ensure compliance with regulatory requirements. Candidates should possess a Bachelor's degree in Chemical Engineering or related fields and have at least 3 years of experience in pharmaceutical manufacturing. Knowledge of Quality Management Systems and tools like SAP-QM is essential. The role involves investigating incidents, performing root cause analysis, and conducting risk assessments to uphold quality standards.

Qualifications

• At least 3 years experience in the pharmaceutical manufacturing environment.
• Knowledge of ISO9001, ICH10, and ISO13485 regulations.
• Experience in biotechnology or biopharmaceutical manufacturing is preferred.

Responsibilities

• Support the company’s mission through formal CAPA program implementation.
• Investigate incidents and perform root cause analyses.
• Monitor effectiveness of corrective actions and risk assessments.

Skills

Quality Management System knowledge

Root Cause Analysis

Project Management

Risk Assessment

Microsoft Excel

Education

Bachelor's Degree in Chemical Engineering or related field

Tools

SAP-QM

Trackwise

Job description

A leading pharmaceutical company in Durban is seeking a Quality Assurance Specialist to manage a formal CAPA program and ensure compliance with regulatory requirements. Candidates should possess a Bachelor's degree in Chemical Engineering or related fields and have at least 3 years of experience in pharmaceutical manufacturing. Knowledge of Quality Management Systems and tools like SAP-QM is essential. The role involves investigating incidents, performing root cause analysis, and conducting risk assessments to uphold quality standards.