MSAT Specialist

Key Responsibilities

• Prepare technical transfer documentation including Master Process Transfer Protocols (MPTP)
• Create Detailed Failure Mode and Effect Analysis (dFFA)
• Develop SSPD documentation
• Conduct Quality Risk Assessments (QRA)
• Create Technical Run Monitoring Protocols/Reports
• Develop Manufacturing Control Strategies (MCS)
• Create Validation Control Strategies (VCS)
• Draft and review process validation protocols
• Coordinate with internal stakeholders
• Ensure timely completion of technical documentation
• Support Technical Transfer Team with related assignments

Requirements

Education

Bachelor's or Master's degree in Chemical Engineering, Biotechnology, Life Sciences, or related field

Experience

3-5 years

Required Skills

• Technical writing
• Attention to detail
• Document management
• Organizational skills
• Time management
• Communication skills
• Knowledge of regulatory guidelines
• Manufacturing science and technology
• Technical transfer
• Process validation

Benefits

• Additional leave
• Annual leave (18 days)
• Dental insurance
• Health insurance
• Professional development assistance
• Elderly Care Leave (3 days)