Present information required during audits according to Standard Operating Procedures (SOPs)

Develop audit checklists and forms for respective manufacturing processes and related departments

Consolidate audit findings and prepare reports on quality performance

Assist to identify potential quality issues with manufacturing processes and products from audit results

Analyse audit reports to highlight gaps in quality assurance and training needs

Implement improvement initiatives and support training activities to address gaps in quality procedures

Record details of customer complaints and assist with investigations

Support product registration and batch release activities by collecting and organising the information required

Develop quality assurance procedures in compliance with the organisation’s policies and regulatory requirements

Scope and plan internal audits in accordance with internal and external requirements

Facilitate external quality audits and review findings

Analyse trends in the quality performance of manufacturing facilities to identify gaps

Analyse customer complaints to identify contributing factors and escalate issues accordingly to appropriate staff for follow-up action

Prepare product registration reports

Review completed batch reports and checklists

Recommend interventions and initiate or refine training programmes to close quality gaps and address non-compliances

Present and explain relevant quality records and audit reports to stakeholders as required

Formulate the organisation's quality assurance policies and objectives in accordance with regulatory standards

Oversee the completion and proper documentation of all quality assurance activities

Review the alignment of Standard Operating Procedures (SOPs) with Current Good Manufacturing Practices (CGMPs)

Liaise with external suppliers and clients to ensure quality parameters are clearly defined

Lead preparations for external audits and conduct opening and closing meetings

Review results of external audits and determine critical changes to processes and procedures required

Obtain approval from stakeholders to disclose information required by external auditors

Oversee product registration and batch release activities and delegate responsibilities to staff accordingly

Lead investigations into major customer complaints

Manage biopharmaceutical product recalls

Devise quality assurance strategies for the organisation to achieve its objectives, based on industry best-practices and regulatory requirements

Direct product registration and batch release activities

Identify implications of changes to regulatory requirements on the organisation’s Standard Operating Procedures (SOPs)

Deliver organisation- wide updates on new or amended legislative or regulatory requirements and their impact on quality assurance strategies

Establish processes for the effective review of quality assurance policies and objectives

Inspire a quality culture across the organisation and direct training activities across manufacturing facilities

Spearhead incentives or reward schemes to encourage the adoption of quality assurance policies and procedures

Manage major customer complaints and associated product recall activities