QUALIFICATIONS NEEDEDBachelors or higher degree in chemistry/biotechnology/pharmacy/engineering or equivalent NECESSARY EXPERIENCE & INDUSTRY ACCREDITATION / KNOWLEDGEGood working knowledge of aseptic (sterile) manufacturing processesAt least 10 years of process, equipment and project design and execution experience within the sterile pharmaceutical /biotech manufacturing industryExperience in managing and executing multi-disciplinary projects in excess of R100 millionExcellent understanding of process flows and key metrics within a sterile manufacturing environmentExcellent understanding of the cGMP guideline relating to sterile productsExperience in initiating, planning, executing, and closing projectsExperience in the control and monitoring of project progress and risksIndependent decision makers, able to debate and lead change managementAble to lead conceptual design regarding processes/ equipment/ structural design etc.
Microbiological knowledge essentialPrevious project work and proven ability to convert guidelines into design specs KEY DUTIES & RESPONSIBILITIES OF THE ROLEEnsures that projects are properly scoped with clearly defined deliverables and clear execution plansTo execute the full range of technical project activities including design, scoping, budgeting, scheduling and execution for successful delivery in line with organisational requirementsTo develop technical standards and user requirement specificationsIdentify and escalate risks and mitigation/recovery plansCreate project budget and ensure adherence to the prescribed budgetRequest approval for changes from necessary stakeholders and manage changes via project change request processesEnsure that the quality criteria is properly defined for each deliverable and frequently measured and reportedEnsuring all designs are cost effective and value adding for the companyExecute/provide technical advice for process and or equipment processesConduct manufacturer visits to perform design reviews, risk analysis, FAT as well as receive training from manufacture for the relevant equipmentCompile the necessary documentation upon completion of manufacturer visit and trainingConduct 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 timelinesProcess equipment SOPs, specifications, qualification documents and MBRs are generated through the appropriate review process and in place for production within the required timelineEnsures that the project delivery is in line with agreed Sterile Products cGMP guidelinesEnsures process design meets quality criteria
