Pharmaceutical Manufacturing Technologist
The Recruitment Agency South Africa
PortElizabeth, South Africa
1h ago
source : Job Placements

Overview

Position : Pharmaceutical Manufacturing Technologist

Salary : Market Related & negotiable

Location : Port Elizabeth

  • Send detailed CV in Word Document, copy of Id, head and shoulders photo of yourself, pay slip, plus Qualifications urgently to speed up your application!!!!!!
  • Applicants are invited to apply for this excellent opportunity that exists for the above mentioned position. The successful incumbent will report to the Manufacturing SME.

    We encourage you to apply for the above which will be ring-fenced for employees who have been mapped to this role only according to skills retention criteria.

    Kindly be advised that only permanent employees are eligible to apply.

    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 and supports continuous improvement.

    Responsibilities

    Planning 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, CAPA"s, OOSs 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 Required

    Background / experience

  • 4 to 6 years experience in technical transfer , with two years in a pharmaceutical manufacturing environment, or one to two years experience in relevant manufacturing environment
  • Bachelors 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
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