QUALITY & COMPLIANCE SPECIALIST – Fabupharm 1 view

VACANCY:

QUALITY & COMPLIANCE SPECIALIST

Location: Otjiwarongo

Fabupharm (Pty) Ltd., a leading pharmaceutical and nutraceutical manufacturer, is seeking to appoint a highly experienced Quality Manager to oversee and drive all quality-related activities within our operations.

Minimum Qualifications & Experience:

* Bachelor of Pharmacy (B.Pharm) degree (mandatory).
* Minimum 15 years’ experience in pharmaceutical manufacturing (sterile and non-sterile), including:
* Regulatory affairs (dossier maintenance and review).
* Facility design (HVAC, purified water, and compressed air systems).
* Calibration management, research and development support.
* Extensive experience in validation and qualification of equipment, utilities, processes, packaging, and cleaning.
* Proven track record in pharmaceutical Quality Management, with exposure to WHO, FDA, and PIC/S audits (essential).
* Prior registration as a Responsible Pharmacist in a pharmaceutical manufacturing setting.
* Strong background in staff management and team leadership.

Key Responsibilities:

* Lead and manage all Quality Assurance activities to ensure compliance with cGMP, GDP, and GLP standards
* Provide technical and regulatory support for the preparation and maintenance of dossiers, Site Master Files, Quality Manuals, Validation Master Plans, and protocols
* Drive continuous improvement of pharmaceutical quality systems, including maintaining a robust Quality Risk Management (QRM) system
* Manage and mentor quality department personnel and ensure all staff receive the required training