Qualifications and Skills:
- Bachelors or higher degree in chemistry/biotechnology/pharmacy/ engineering or equivalent.
- 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 /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.
Duties and Responsibilities:
- 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
- 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