GMP Quality Pharmacist - Batch Release & QA

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

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