Senior Technical Lead Pharmaceutical

Cape Town, Western Cape, South Africa

Job Description


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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Job Detail

  • Job Id
    JD1343969
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Cape Town, Western Cape, South Africa
  • Education
    Not mentioned