Senior Technical Lead - Pharmaceutical - South Africa
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
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