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)
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 those appropriate validations are completed as per validation requirements and schedule
- Initiate and set targets and review GMP, quality and training needs
Background/experience
- Minimum of Bachelor’s 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
Accountability & Decision Rights:
- Unit and/or project related results, costs, methods, staffing, managerial planning and integration
- Manage budget (s) for unit and teams
- Apply extensive in-depth and/or broad professional knowledge
- Practical solutions to ensure quality at source, by providing necessary quality references and policies and execute problem solving and risk-based approaches to operational activities
Independent decisions relating to:
- Product, implementing new programmes, processes, and tools, and supporting technical / operational processes
- Use of resources to meet defined objectives and timelines
- Direction regarding approach and priorities for team(s)
- Initiation of changes to processes, procedures and policies that impact immediate operation
Aspen fully subscribes to the principles of Employment Equity and will make decisions in line with this ethos.
