Job Description

Coordinate quality activities, including:

• Interpret and implement quality procedures, standards and specifications
• Preparation of regulatory audits
• Action all audit related activities and responses
• Pro actively initiate continuous improvement activities to improve quality compliance under the guidance of the QS Management

Audit Readiness and Performance

• Participate in site walkabouts and prepare department owners for upcoming audits
• Compile documentation required for external audits
• Review compliance status of the facility and highlight risks to the quality team
• Prepare teams and documentation prior to presentation to the auditors
• Co ordinate activities and documentation requests during site audits

Audit CAPA Management

• Liaise with department owners to compile audit responses to external audit observations, according to the required standard
• Maintain status updates of the audit CAPA actions for both internal and external audits
• Timeously prepare external audit responses for submission

Operational Support

• Track continuous improvement actions identified and ensure effective implementation thereof
• Assist with preparation and review of documentation requested by external customer and regulatory bodies
• Take part in project risk assessments for introduction of new products/facility changes

Policy, procedure and document management

• Provide input into policies and procedures with regards to latest authority expectations
• Draft and maintain SOPs relevant to the functions performed by the department
• Review site procedures for compliance to regulations and Group Operations Quality Compliance

Review and reporting

• Compile audit CAPA update reports for submission to external and internal stakeholders
• Update the Quality CES audit matrix with the latest status of observations

Background/experience

• Minimum of Bachelor's Degree (BPharm) or relevant scientific qualification
• Knowledge of regulatory guidelines
• Minimum 4-6 years' related work experience
• Pharmaceutical manufacturing experience
• QMS experience is advantageous
• Regulatory audit experience is advantageous

Specific job skills

• Strong working knowledge of pharmaceutical manufacturing and corrective action programs
• Pharmaceutical standards and compliance requirements
• People skills and working well with others
• Report writing skills

Competencies

• Offering Insights
• Taking Action
• Information gathering
• Interrogating information

Skills Required