Manufacturing Technologist
Aspen Pharma Group
Date: 4 days ago
City: Port Elizabeth, Eastern Cape
Contract type: Full time
Overview
Planning and project support
Skills Required
- 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.
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.
- Manage aspects of tech transfer projects, including:
- Feasibility and risk assessment
- Planning
- Trial and validation batch manufacturing
- Execution and tracking.
- 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, OOS’s and technical complaints
- 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
- 4 to 6 years’ experience, with at least two years in a pharmaceutical manufacturing environment, or 1 to 2 years’ experience in relevant manufacturing environment
- Bachelor’s degree in Pharmacy, Engineering or similar.
- 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.
- Offering Insights
- Investigating Possibilities
- Innovative Thinking
- Technical / scientific report writing
- Data analysis
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