Responsible Pharmacist – Regulatory & Quality Assurance

About the role

The Responsible Pharmacist is a legal appointment required by SAHPRA for the manufacturing, warehousing, distribution and marketing of pharmaceutical products. In this position you will provide regulatory, quality and manufacturing oversight for medicinal gases, ensuring compliance with cGMP, GPP, SOPs and relevant legislation.

Key responsibilities

• Manage all regulatory interactions with SAHPRA, including licence applications, product registrations and variations.
• Maintain compliance with the Medicines and Related Substances Act and ensure inspection readiness.
• Oversee the Quality Management System (QMS) and ensure adherence to GMP standards.
• Review and approve batch records, manage product release, change control, CAPA, deviation investigations and risk assessments.
• Lead validation and qualification activities for equipment, processes and cleaning.
• Conduct internal and external quality audits, prepare for SAHPRA inspections and implement corrective actions.
• Handle product quality complaints, investigations and adverse event reporting.
• Provide GMP and regulatory training to staff and promote a culture of compliance.

Required profile

• Bachelor of Pharmacy (BPharm) and registration with the South African Pharmacy Council.
• Eligibility to act as a Responsible Pharmacist in South Africa.

Required skills

• cGMP implementation
• Good Pharmacy Practice (GPP)
• CAPA management
• Validation and qualification
• Risk assessment
• Batch record review