Job 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.

• 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, CAPAxe2x80x9d s, OOSxe2x80x99s 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.

• 4 to 6 yearsxe2x80x99 experience, with at least two years in a pharmaceutical manufacturing environment, or 1 to 2 yearsxe2x80x99 experience in relevant manufacturing environment
• Bachelorxe2x80x99s 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