GMP Lead (Gqeberha) at Aspen Pharma Group

Description

• Responsible for ensuring consistent GMP compliance across sterile and OSD manufacturing operations. Leads contamination control, GMP governance, validation, environmental monitoring and inspection readiness to ensure a strong, risk-based quality culture across the site

Requirements

• Lead and maintain the site-wide Contamination Control Strategy (CCS).
• Ensure GMP compliance across sterile and OSD manufacturing.
• Oversee environmental monitoring and cleanroom controls.
• Provide GMP oversight of aseptic processing, sterilisation and contamination control.
• Ensure effective contamination and cross-contamination controls in OSD manufacturing.
• Standardise GMP, data integrity and quality practices across the site.
• Oversee validation activities for processes, equipment and utilities.
• Drive inspection readiness and support regulatory and customer audits.
• Identify, assess and manage GMP and contamination risks.
• Use quality data and trends to identify risks and improvement opportunities.
• Drive continuous improvement and operational excellence across GMP processes.

Qualification:

• Bachelor's or Master's degree in Pharmacy, Microbiology, Chemistry, Engineering or a related scientific field.

Experience: 

• 15+ years' experience in a GMP-regulated pharmaceutical manufacturing environment.
• 10+ years' management experience.
• Experience in both sterile and OSD manufacturing.
• Experience supporting regulatory inspections and audits