Job Description
Job Responsibility and key Decisions
Responsibilities
Assist in monitoring and executing downstream process steps during manufacturing batches.
Support technology transfer and scaleup activities by ensuring process adherence and documentation.
Participate in troubleshooting downstream process deviations or abnormalities.
Maintain process and batch documentation in compliance with GMP.
Support continuous improvement initiatives by providing data and observations.
Assist in preparation for audits and regulatory inspections by ensuring data completeness.
Key Decisions
Identify and report process abnormalities or deviations promptly.
Decide when to seek assistance from senior MSAT or Quality personnel for unresolved issues.
Recommend process adjustments under guidance within established parameters.
Determine appropriate documentation of process events and deviations.