GMP Lead (Gqeberha)

Aspen Pharma Group · Port Elizabeth, Eastern Cape

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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.

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