- Monitor product quality throughout the manufacturing and packaging process
- Monitor QMS compliance with GMP standards
- Assist with deviations and quality investigations
- Provide input into SOPs to ensure compliance
- Related administrative tasks
Planning and Process
- Plan and coordinate administrative activities
- Provide recommendations on process improvements
- Verify production plans for operation effectiveness
- Perform line opening visual inspections as per checklist
- Perform end-of-batch internal inspections to assess compliance and effectiveness of overall QMS
- Perform on-line inspections of batch documents during manufacturing and packaging process to assess compliance
- Perform inspections to monitor GMP compliance during manufacturing
- Perform inspection of logbooks, SOP files and AQL
- Perform final inspection of finished goods
- Raise deviations for non-conformances identified
- Record and report quality problems as they are identified
- Compile and issue report on non-conformances and ensure adequate CAPA plans have been implemented
- Assist with product and quality investigations
- Review and provide input into SOPs to ensure compliance to GMP standards and product specifications
- Establish and apply continuous improvement processes
- Monitor and audit compliance to regulatory and in-house standards with regards to current GMP
- Participate in audits when required
- Participate in unit risk assessments
- Coordinate and consolidate the gathering of information for reporting
- Compile detailed reports and documents
- Monitor and control data integrity in all databases
- Communicate with employees and management, to assist and convey information
Skills Required
- Grade 12 with 6+ years related experience, or 2-year Diploma with 4+ years related experience
- Pharmaceutical manufacturing experience
- Strong working knowledge of pharmaceutical quality operations and quality management systems
- Pharmaceutical standards and compliance requirements
- Ability to interpret and implement policies, processes and objectives
- Information Gathering
- Following Procedures
- Capturing Facts
- Taking Action
