Job Description

Overview

• Ensure evaluation or testing and control of starting materials, consumables, components, intermediaries, bulk and finished products in accordance with Quality procedures, standards, specifications to meet planned requirements
• Develop, manage, monitor and approve Standard Operating Procedures, Methods of Analysis, specifications, protocols and reports in compliance with latest regulations
• Ensure appropriate method validations are performed and up to date
• Long term strategic planning for unit
• Manage, guide and monitor QC Laboratory activities through Team Leaders
• Staff management of direct reports and entire department (KPIs, performance reviews, disciplinary actions and other IR responsibilities)
• Risk identification and solution
• Approve all training to be implemented in the laboratory and ensure unit staff's training are appropriately trained (initial training as well as re-training and qualification)

Skills Required
Background/experience

• Minimum of Bachelors Degree preferred
• 10 years' related work experience
• Pharmaceutical manufacturing experience

Specific job skills * Advanced understanding of pharmaceutical testing methods

• Understanding of pharmaceutical manufacturing and corrective action programs
• Pharmaceutical standards and compliance requirements
• Ability to interpret and implement policies, processes and objectives

Competencies * Innovative Thinking

• Interrogating Information
• Offering Insights
• Managing Performance
• Networking

Responsibilities
Strategic Planning and Unit Management

• Interpret, implement and coordinate systems, processes, policies and procedures in the unit
• Provide technical and operational input into systems, procedures and policies that impact in-process control activities in value stream operations
• Perform human capital functions to ensure optimal management of unit and reporting sections
• Manage collaboration and coordination between reporting units
• Responsible to lead projects directly related to the value stream laboratories (Chemistry and Microbiology)
• Liaise, interact and provide technical guidance to QA and Production Managers
• Propose changes / improvements to processes, systems, tools and techniques
• Lead L2 and attend L3 meetings

Financial Planning, Financial Management and Resource Management * Develop and monitor the functional plan / budget (OPEX and CAPEX) of the value stream laboratories (Chemistry and Microbiology)

• Ensue availability and optimal allocation of resources within unit

People Management and Development * Implement Human Capital Policies

• Identify training needs and monitor training compliance
• Participate in training, coaching and development of team members
• Develop and implement performance contracts and succession plans
• Manage conflict, disciplinary and safety issues
• Assist with recruitment

Release Starting Materials, Packaging Materials, Consumables, Intermediate, Bulk and Finished Products

• Lot release and/or rejection of starting materials, packaging materials, consumables, components, intermediate, bulk and finished goods
• Approve compliance of QC laboratory preparation and testing activities to GMP, quality standards and product specifications
• Ensure all testing is carried out as agreed / scheduled
• Ensure laboratory outputs meet the agreed standard

Approve Specifications, Sampling Instructions, Test Methods, other QC Procedure and Validation Documents * Review and approve the documents to comply with technical, GMP and Data Integrity requirements
Analytical Method Validation and Analytical Method Transfer * Take the lead and ensue the relevant value stream laboratory AMT activities are executed

• Manage the method transfer activities against deadlines to ensure effective and accurate compilation of raw material and finished product specifications
• Provide scientific and technical expertise and manage communication with Analytical Method Transfer partners

Governance, Risk, Compliance to QMS and keep unit compliant to cGMP guidelines * Ensure unit's activities comply with current operating guidelines and policies for the organisation and function

• Monitor and correct compliance with legislation, policies and procedures to impact on the effectiveness of QC activities
• Ensue that appropriate validations are completed as per validation requirements and schedule
• Initiate and set targets and review GMP, quality and training needs

Aspen fully subscribes to the principles of Employment Equity and will make decisions in line with this ethos.
Closing date: 12 November 2025

Skills Required