Manufacturing Technologist

Port Elizabeth, Eastern Cape, South Africa

Job Description


Overview

  • Provide technical / scientific support for internal and external technology transfer of manufacturing processes
  • Implement process validation activities and post-transfer support
  • Trouble shoot problems encountered during tech transfer / process optimization / commercial manufacture
  • Supports continuous improvement
ResponsibilitiesPlanning and project support
  • Research and report on solutions to improve tracking, planning and collaboration
  • New product introduction assessment
  • Technical evaluation of products and processes
  • Draft transfer protocols, project plans and timelines and prepare proposals and status reports
  • Compile technical documents that comply with local and international regulatory guidelines
  • Support technology transfer team activities and projects
  • Identify project issues and recommend methods for resolution
Project management
  • Manage aspects of tech transfer projects, including:
  • Feasibility and risk assessment
  • Planning
  • Trial and validation batch manufacturing
  • Execution and tracking
Manufacturing science, technology troubleshooting
  • Provide planned and unplanned production support
  • Troubleshoot process / product problems
  • Guide during process changes, process optimization including API/IPI source changes
  • Provide manufacturing science & technical support for deviations, CAPAxe2x80x9ds, OOSxe2x80x99s and technical complaints
Risk management and process validation
  • Conduct feasibility and risk assessments
  • Ensure that project planning encompasses quality, risk and process validation aspects
  • Ensure regulatory compliance throughout tech transfer processes
  • Support investigations associated with tech transfer activities
  • Carry out Process Qualification (PQ) and Continued Process Verification (CPV) activities to validate transferred processes
Skills RequiredBackground/experience
  • 4 to 6 yearsxe2x80x99 experience, with at least two years in a pharmaceutical manufacturing environment, or 1 to 2 years experience in relevant manufacturing environment
  • Bachelorxe2x80x99s degree in Pharmacy, Engineering or similar
Specific job skills
  • Knowledge of Pharmaceutical technical issues, manufacturing processes and operations environment
  • Knowledge of validation, regulatory affairs, R&D, and new product transfer
  • Knowledge of local and international pharma guidelines
Competencies
  • Offering Insights
  • Investigating Possibilities
  • Innovative Thinking
  • Technical / scientific report writing
  • Data analysis

Aspen Pharmacare

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Job Detail

  • Job Id
    JD1352240
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Port Elizabeth, Eastern Cape, South Africa
  • Education
    Not mentioned