Job Responsibilities:
- 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 adhered to correctly.
- Perform quality risk assessments, establish risk controls, and review risks to assist with the quality risk management process.
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 of 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 a weekly/monthly basis, as required by superiors.
- Compile and complete standardized reports and consolidate standardized documents.
Skills Required:
Educational Qualifications & 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
- Meets Deadlines
- Taking Action
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