- 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.
RESPONSIBILITIES:
Planning and Operational Support
- Plan and coordinate administrative activities
- Provide recommendations on process improvements
In-Process Quality Management
- 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
Reporting
- Coordinate and consolidate the gathering of information for reporting
- Compile detailed reports and documents
- Monitor and control data integrity in all databases
Communication
- Communicate with employees and management, to assist and convey information
Background/experience
- Grade 12 with 6+ years’ Quality experience, or 2 year Diploma with 4+ years’ Quality experience
- Pharmaceutical manufacturing experience
Specific job skills
- 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
Competencies
- Information Gathering
- Following Procedures
- Capturing Facts
- Taking Action
Aspen is committed to the principles of equal employment opportunity and suitably qualified job applicants are invited to submit their CVs online on or before the specified date. Preference will be given to applicants from designated groups, through a fair recruitment and selection process, in accordance with laws governing employment equity, where such laws are applicable to the Aspen entity that will employ the successful candidate.
Only short-listed candidates will be contacted, thus if you have not heard from the HR department within 30 days of this advert closing, please consider your application unsuccessful.
Internal Applicants must inform their direct line managers of their application. Applications must be completed using an Aspen email address.