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 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