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Square Pharmaceutical, Inc. is seeking a qualified candidate to join our Product Development team. Responsibilities include developing new drug and dietary supplement molecules, improving formulations, preparing samples for regulatory registration, and ensuring GMP compliance.
The role covers creating specifications, coordinating material availability, and preparing ACTD Part II-Quality documents, with emphasis on timely delivery and problem solving.
Bachelor's Degree in Pharmacy, Chemistry, Chemical Engineer or Biochemistry
Proficient in Microsoft Office, Technical Writing, Analytical/Troubleshooting and Problem-Solving Skills
Preferably have an experience in Product Development; Process Validation
Develop new product molecules of drug and food supplement that are safe, effective, good quality and affordable with shortest throughout time to meet customers requirement
Improve formulation and process of existing products, adopting current or latest technology
Assist for preparation of samples for initial registration
Monitor samples for stability study (actual and accelerated stability study)
Create technical specifications for new materials and new products and improve existing specifications
To meet targets/deliver results through responsible planning, organizing and completing tasks assigned to you
Request and ensure materials availability for development
Coordinate closely with superior on product development concerns. Escalate to superior problems, issues and concerns with analysis, conclusion and recommendation
Prepares unit dose formulations, manufacturing procedures, and stability study protocols and reports
Prepares product development-related documents as per requirement of the ASEAN Common Technical Dossier (ACTD), specifically in Part II-Quality
Ensure strict compliance to GMP requirements all the time