Quality Pharmacist (Port Elizabeth) at Aspen Pharma Group

Requirements

Planning and Process

• Provide technical and operational input during drafting of plans and procedures specific to unit.
• Implement and coordinate systems and procedures and make decisions within policies and procedures, or as authorized by superiors.

Product Release

• Review batch documentation and production conditions to assess compliance to quality procedures, standards, and product specifications.
• Review and approve quality of new, in-process and released batches to assess compliance to quality control programs, product specifications, and GMP guidelines.
• Approve and release production batches.
• Execute batch release priorities in line with OTIF and planning schedule.
• Ensure release requirements are met for finished products.
• Determine disposition of in-process and finished products for clinical and commercial use.
• Ensure changes/ deviations in production or quality control have been approved according to QMS.
• Initiate tests/ checks/ inspections/ sampling to mitigate any risk associated with planned changes/ deviations.
• Ensure production and QC documentation are completed in compliance with SOPs.
• Monitor and audit compliance to regulatory and in-house standards with regards to current GMP
• Report observed deficiencies in process and follow up on corrective action.
• Investigate systematic quality problems and develop preventative plans, in conjunction with Production.

Process Compliance

• Identify systematic technical and process issues by reviewing CAPA requests and trends.
• Systematic investigation of the root causes of identified problems and risks for corrective action or prevention.
• Develop CAPA plans and change incidents to address process compliance.
• Implement operational changes to SOPs and processes, in compliance with control processes.
• Ensure deviations (planned/ unplanned) are documented, reviewed, and analyzed and recommend validation activities to be performed.
• Execute change control process by ensuring changes are documented, reviewed, and approved.

Annual Performance Quality Review

• Review APQRs to assess production risks and quality of in-process control programs.
• Review and analyze CAPA plans to assess impact on quality procedures and standards.

Retention Sample Management

• Store and manage retention samples as per guidelines.

In Process Quality Management

• Review and approve outcome if in-process internal inspections.

Skills Required

Background/Experience

• BPharm Degree with 2 years’ pharmaceutical manufacturing experience
• South African Pharmacy Council registration
• 1-year related work experience