In Process Quality Officer at Aspen Pharma Group

Job Overview:

• 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 Process

• 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

Requirements

Skills Required

Background/experience

• Grade 12 with 6+ years’ related experience, or 2-year Diploma with 4+ years’ related 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