Job Summary
QUALIFICATIONS NEEDED
- Bachelors or higher degree in chemistry/biotechnology/pharmacy/engineering or equivalent
-
NECESSARY EXPERIENCE & INDUSTRY ACCREDITATION / KNOWLEDGE
- Good working knowledge of aseptic (sterile) manufacturing processes
- At least 10 years of process, equipment and project design and execution experience within the sterile pharmaceutical /biotech manufacturing industry
- Experience in managing and executing multi-disciplinary projects in excess of R100 million
- Excellent understanding of process flows and key metrics within a sterile manufacturing environment
- Excellent understanding of the cGMP guideline relating to sterile products
- Experience in initiating, planning, executing, and closing projects
- Experience in the control and monitoring of project progress and risks
- Independent decision makers, able to debate and lead change management
- Able to lead conceptual design regarding processes/ equipment/ structural design etc. Microbiological knowledge essential
- Previous project work and proven ability to convert guidelines into design specs
KEY DUTIES & RESPONSIBILITIES OF THE ROLE
- Ensures that projects are properly scoped with clearly defined deliverables and clear execution plans
- To execute the full range of technical project activities including design, scoping, budgeting, scheduling and execution for successful delivery in line with organisational requirements
- To develop technical standards and user requirement specifications
- Identify and escalate risks and mitigation/recovery plans
- Create project budget and ensure adherence to the prescribed budget
- Request approval for changes from necessary stakeholders and manage changes via project change request processes
- Ensure that the quality criteria is properly defined for each deliverable and frequently measured and reported
- Ensuring all designs are cost effective and value adding for the company
- Execute/provide technical advice for process and or equipment processes
- Conduct manufacturer visits to perform design reviews, risk analysis, FAT as well as receive training from manufacture for the relevant equipment
- Compile the necessary documentation upon completion of manufacturer visit and training
- Conduct the necessary research in order to contribute towards ensuring that the process equipment (new equipment) is qualified (IQ, OQ) and ready for production activities within the project timelines
- Process equipment SOPs, specifications, qualification documents and MBRs are generated through the appropriate review process and in place for production within the required timeline
- Ensures that the project delivery is in line with agreed Sterile Products cGMP guidelines
- Ensures process design meets quality criteria