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Aspen has a proud heritage dating back more than 160 years and is committed to sustaining life and promoting healthcare through increasing access to its high quality affordable medicines and products. Aspen has a market capitalisation of approximately US$10 billion, is the largest pharmaceutical company listed on the JSE Limited (share code: APN) and rank…
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Overview
- Develop, manage and monitor quality procedures, standards and specifications for value streams in compliance with regulations
- Manage and monitor core QA activities for value streams
- Review and approve in-process QA programs and activities
- Manage and guide the unit through team leaders
- Performance management of direct reports and unit
Responsibilities
Planning & Processes
- Interpret, implement, and coordinate systems, processes, policies and procedures contributing to the quality assurance in the unit
- Provide input into existing systems, procedures and policies that impact in-process control activities in value stream operations and quality in the unit
- Attend L2-3 meetings
Financial & Resource management
- Provide input into the functional financial plan/ budget based on operational requirements
- Ensure availability and optimal allocation of resources within unit
People Management & Development
- Implement human resource policies
- Participate in training, coaching and development for team members
- Develop and implement performance contracts and succession plans
- Manage conflict, disciplinary and safety issues
- Assist with recruitment
Product Release
- Lot release and/or rejection of starting materials, packaging materials, intermediate, bulk and finished products.
- Review and approve process to release disposition of products
- Determine batch release priorities in line with On Time In Full (OTIF) and planning schedule requirements
- Perform batch release when required
- Process Compliance
- Review and approve CAPA plans to address systematic issues
- Review and approve operational changes to SOPs and processes
In Process Quality Management
- Review and approve process for in-process quality management
- Ensure effective Review and Monitoring of Supplier management system
Governance, Risk & Compliance
- Participation in Management reviews and escalation of quality issues
- Ensure unit’s activities comply with operating guidelines and policies for the organisation and function.
- Monitor and correct compliance with legislation, policies and procedures to impact on the effectiveness of QMS
- Review and approve Document Retention procedures
Requirements
Skills Required
Background/experience
- Minimum of Bachelor’s degree (BPharm) preferred
- 7 years’ related work experience
- Pharmaceutical manufacturing experience
Specific job skills
- Strong working knowledge of pharmaceutical manufacturing and corrective action programs
- Pharmaceutical standards and compliance requirements
- People management
- Ability to interpret and implement policies, processes and objectives
Competencies
- Interrogating Information
- Offering Insights
- Managing Performance
- Planning and Organising