Technology Transfer Specialist - Pharma

Mô tả Công việc
Prepare lab trial batches to support research and testing activities during technology transfer, including:
- Evaluation of raw material changes, manufacturing process adjustments, process improvements, and troubleshooting.
- Collaborate with QC and QA to conduct stress tests to assess the impact of changes on product quality and manufacturing processes.
- Collaborate with QA and QC teams to implement and monitor stability studies, ensuring compliance with quality and regulatory requirements.
- Work with cross-functional teams to analyze test results and support decision-making on proposed changes.
- Prepare reports on trials and evaluation outcomes.
Participate in process validation:
- Prepare process validation protocols.
- Monitor and record parameters during validation batch production.
- Perform sampling at key stages (e.g., blending, compression, coating, blistering).
- Package samples for stability studies.
- Prepare process validation reports.
Support other technology transfer activities:
- Review and analyze product registration dossiers from the sending site.
- Assess product formulations, manufacturing processes, testing procedures, and related technical documentation received from the sending site to determine suitability for production
Perform other tasks assigned by Site Technology Transfer & Innovation Head