- 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.
- 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.
- 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.
- 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.
- 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.
- Store and manage retention samples as per guidelines.
- Review and approve outcome if in-process internal inspections.
Background/Experience
- BPharm Degree with 2 years pharmaceutical manufacturing experience
- South African Pharmacy Council registration
- 1-year related work experience
- Information Gathering
- Interrogating Information
- Finalizing Input
- Offering Insights
- Meets Deadlines
- Taking Action
