Compliance Specialist (Port Elizabeth) at Aspen Pharma Group

Description

Overview

• 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

Requirements

Responsibilities

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