Quality Assurance Specialist - Pharmaceutical Manufacturing

Synopsis

A pharmaceutical manufacturing environment requires a Quality Assurance Specialist to support its Quality Management System and help clear outstanding quality-related activities. This fixed-term position focuses on cGMP compliance, electronic quality workflows, incident management, change control, customer complaints and controlled-document review within a regulated manufacturing environment.

Key Responsibilities

• Process and close outstanding Quality Management System activities within agreed timelines.
• Manage quality tasks relating to incidents, changes and customer complaints.
• Complete controlled-document reviews and associated quality-system administration.
• Conduct and document risk assessments where required.
• Ensure open notifications and quality records are completed accurately.
• Support continued compliance with current Good Manufacturing Practice requirements.
• Maintain quality processes in accordance with relevant ISO 13485 requirements.
• Use electronic quality-management and SAP-based workflows to manage assigned quality activities.

Qualifications / Minimum Requirements

• Matric plus a relevant tertiary qualification in Chemical Engineering, Biological Sciences, Chemistry, Pharmaceutical Sciences or a related discipline.
• At least two years of Pharmaceutical Manufacturing or Quality Assurance experience in a cGMP environment.
• At least two years of experience working with an electronic Quality Management System.
• Quality Management qualifications are advantageous.
• SAP experience is advantageous.
• Experience with sterile or biological pharmaceutical products is advantageous.