QA Manager (Port Elizabeth) at Aspen Pharma Group

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 meeting

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

• 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

In Process Quality Management

• Review and approve process for in-process quality management
• Ensure effective Review and Monitoring of Supplier management system

Requirements
Skills Required

Background/experience

• Minimum of Bachelor’s degree (B Pharm) or Masters degree advantageous
• 5 – 8+ years’ experience in a pharmaceutical QA environment including
• 3 – 5+ years’ experience in a management role

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