GREEN SPEED Việt Nam ★ 3.3

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

Yêu Cầu Công Việc

-       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)