Job Description

• Compilation of documents required for audit purposes.
• Logging and tracking of audit CAPA commitments.
• Preparation of QA Compliance related documentation where requested.

Process improvement and support

• Carry out continuous improvement activities under supervision of the QS management team
• Tracking of continuous improvement and compliance activities, including risk assessments
• Maintain SOPs within the QS department

Operational QS Support

• Assist with document collation requests for external customers and regulatory bodies as requested by QS Management
• Assist with data collation and report writing in the QS department
• Audit Activities
• Assist with the documentation requests prior to- and during GMP audits
• Communicate audit requirements, recommendations and processes with relevant departments
• Gather evidence for completed CAPA commitments

Reporting and analysis

• Assist with data generation and trending of data for analyses and reporting
• Compile initial audit response reports for review
• Consolidate information for reports specific to area of responsibility
• Track all audit external and internal CAPA commitments for QSMR reporting

Planning and procedures

• Plan for and prioritise own tasks and responsibilities, within standards and procedures, to fulfil work requirements
• Determine resource needs of own area of work
• Optimise current processes

Background/experience

• 2 to 4 years' related work experience
• Learnership and registered PMA
• Quality Systems experience

Specific job skills

• Report writing skills
• Working knowledge of local registrations and regulations and of international regulations/guidelines concerning GDP/GMP, QA
• Understanding of the pharmaceutical manufacturing and corrective action programs, pharmaceutical standards and compliance requirements
• Attention to detail
• Sense of urgency and prioritisation

Competencies

• Customer Awareness
• Following Procedures
• Interrogating Information
• Organisational Citizenship

Skills Required