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.

Responsibilities

• 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 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 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.

Requirements
Skills Required

Background/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