Description
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 standard.
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 standardized reports and consolidate standardized documents
Requirements
Background/experience
BPharm Degree with 2 years' pharmaceutical manufacturing experience
South African Pharmacy Council registration
1-year related work experience
Specific job skills
Advanced understanding of the pharmaceutical manufacturing and corrective action programs
Pharmaceutical standards and compliance requirements
Ability to interpret and implement policies, processes and objectives
Competencies
Demonstrate initiative and apply advanced concepts
Exercise interpersonal, communication, training and problem-solving skills to optimise team performance
Escalate highly complex problems or out-of-policy issues
Work on assignments of moderate size, scope, diversity and/ or complexity
Stay up to date on developments, trends, legislation and industry regulations in Pharmaceutical industry