Job Description

Overview

• Conduct in-process compliance to quality procedures, standards and specifications for value stream operations
• Review and approve Annual Performance Quality Review (APQR) and quality related activities
• Ensure in-process materials and finished products comply with GMP guidelines, regulation, and in-house SOPs
• Ensure product release for use into the marketplace ensuring compliance with local regulations, Aspen Ops guidelines and other marketing authorization requirements and guidelines.
• Control of documentation in compliance with regulation and company policies and procedures
• Ensure all relevant GMP and GDP processes are described in the current SOPs and re adhered to correctly.
• Perform quality risk assessments, establish risk controls and review risks to assist with the quality risk management process.

ResponsibilitiesPlanning and Procedures

• 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 authorised 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 analysed and recommend validation activities to be performed
• Execute change control process by ensuring changes are documented, reviewed and approved

Annual Performance and Quality Review

• Review APQRs to assess production risks and quality of in-process control programs
• Review and analyse 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.

Reporting

• Ensure the filing, retrieving, and archiving of documents on the soft and hard copy filing systems.
• Maintain and update records and systems as required.
• Provide information for reports on weekly/monthly basis, as required by superiors.
• Compile and complete standardised reports and consolidate standardised documents.

Skills RequiredBackground/experience

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

Competencies

• Information gathering
• Interrogating information
• Finalizing Input
• Offering Insights
• Meeting deadlines
• Taking action

Aspen Pharmacare