Description

• 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

Requirements

• 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, OOS’s 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 C continued Process Verification (CPV) activities to validate transferred processes

Skills Required

Background/experience

• 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

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