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 yearsxe2x80x99 pharmaceutical manufacturing experience