Technology Transfer Specialist - Pharma

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Job Description

Location: Thu Duc city, 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