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Location: Thu Duc, HCMC
Responsibilities
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
Qualifications
-University degree in pharmacy or chemical pharmacy.
-Minimum 6 months of experience in R&D, production, or quality assurance in a pharmaceutical company.
-Good understanding of GMP, pharmaceutical manufacturing processes, and process validation requirements.
-Experience in trial batch preparation, stress testing, and stability studies is preferred.
-Knowledge or experience in pharmaceutical regulations and drug registration is a plus.
-Basis English (Can read and understand technical documents)
Benefits
Job ID: 137142525
