Job Description

Provides technical / scientific / documentation input for internal and external technology transfer of manufacturing processes. Troubleshoots problems encountered during tech transfer/process optimization. Supports process validation activities and provides input on regulatory queries. 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 Support aspects of tech transfer projects, including:

• Feasibility and risk assessments
• Planning
• Trial and validation batch manufacturing
• Execution and tracking

Manufacturing science, technology

• Execution of lab-scale and trial batch manufacture.
• Assist with execution of validation batch manufacture.
• Provide input regarding process changes and process optimization, including API source changes where relevant.
• Support life cycle approach to product introduction.
• Troubleshoot process / product problems.

Risk management

• Conduct feasibility and quality risk assessments according to local and international regulatory requirements.
• Ensure that project planning encompasses quality, risk and process validation aspects.
• Ensure data integrity and regulatory compliance throughout tech transfer processes.
• Carry out investigations associated with tech transfer activities.
• Support Process Qualification (PQ) activities to validate transferred processes.

Background/experience

• 4 to 6 yearsxe2x80x99 experience, with at least two years in a pharmaceutical 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