Quality Pharmacist

Aspen Pharma Group; Gqeberha; On-site; ZAR 420,000 - 600,000; Full time

Job summary

Aspen Pharma Group in South Africa seeks a Quality Assurance Specialist to ensure pharmaceutical products and manufacturing processes meet GMP, regulatory, quality and company requirements. You review batch documentation, support product release and manage CAPAs while guiding cross-functional teams to uphold SOPs and regulatory standards.

Role emphasizes deviations investigation, risk assessments and ensuring consistent quality across all shopfloor steps, with hands-on QA oversight during

Qualifications

• BPharm degree from a recognized university.
• Registered with the South African Pharmacy Council (SAPC).

Responsibilities

• Review and approve batch and quality documentation.
• Release finished products in line with GMP and regulatory requirements.
• Daily QA oversight during various steps of the manufacturing process to ensure products meet GMP, regulatory and quality requirements before release.
• Investigate deviations, quality issues and process problems.
• Support and review CAPAs, change controls and risk assessments.
• Review and approve production and QC changes.
• Conduct and support quality inspections and compliance checks of shopfloor manufacturing steps and processes.
• Review Annual Product Quality Reviews (APQRs).
• Manage retention samples according to requirements.
• Maintain accurate quality records and documentation.
• Prepare and provide quality reports.
• Identify quality risks and recommend corrective or preventive actions.
• Provide guidance and support to Production and other relevant teams.
• Ensure SOPs, GMP requirements and regulatory standards are consistently followed.

Skills

Quality Assurance

GMP compliance

Documentation control

Batch release

CAPA & change control

Deviation investigation

Regulatory standards

Cross-functional guidance

Education

BPharm Degree

Job description

Responsible for ensuring that pharmaceutical products and manufacturing processes meet GMP, regulatory, quality and company requirements. The role reviews and approves quality documentation, supports product release, manages quality risks and ensures that deviations, CAPAs and changes are properly controlled.

• Review and approve batch and quality documentation.
• Release finished products in line with GMP and regulatory requirements.
• Daily QA oversight during various steps of the manufacturing process to Ensure products meet GMP, regulatory and quality requirements before release.
• Investigate deviations, quality issues and process problems.
• Support and review CAPAs, change controls and risk assessments.
• Review and approve production and QC changes.
• Conduct and support quality inspections and compliance checks of shopfloor manufacturing steps and processes.
• Review Annual Product Quality Reviews (APQRs).
• Manage retention samples according to requirements.
• Maintain accurate quality records and documentation.
• Prepare and provide quality reports.
• Identify quality risks and recommend corrective or preventive actions.
• Provide guidance and support to Production and other relevant teams.
• Ensure SOPs, GMP requirements and regulatory standards are consistently followed.

Qualification

• BPharm Degree.
• Registered with the South African Pharmacy Council (SAPC).

Experience

• Approximately 2 years' pharmaceutical manufacturing experience.
• Experience in Quality Assurance, GMP and pharmaceutical quality systems.
• Experience with batch release, deviations, CAPA and change control is advantageous.