REMED Pharmaceuticals, Inc. Licensed Pharmacist

REMED Pharmaceuticals, Inc.

NT$12.9-25.7K[月薪]

现场办公 - 帕西格1-3年经验本科全职

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Support regulatory activities such as review of documents for renewal of licenses, Certificate of Product Registration (CPR), handling , and other applications for submission to Food and Drug Administration (FDA).
Regularly review product dossier and labeling & packaging materials of existing products by ensuring that all information complies with FDA Guidelines.
Ensure compliance with FDA rules & regulations and company policies and procedures.
Always give updates and be in close communication with local suppliers, for all regulatory concerns, and documentary requirements.
Conducts regular checking of storage & warehouse, ensuring products are stored in the correct manner and adhering to standard warehouse procedures.
Conducting an internal quality inspection of incoming goods and performing random sampling, ensuring inspection is being done for final investigation for product Quality Assurance (QA), reports must be submitted to the superiors on a regular basis.
Assisting with product queries and complaints and creating investigational reports.
Monitor complaints and ensure that all are acknowledged in a timely manner and keeping distributors/manufacturers informed of the complaints

Licensed Pharmacist
At least two years experience in regulatory affairs either in distribution, manufacturing industry or importation
Knowledgeable in FDA regulations, Good Storage Practices (GSP), Good Distribution Practices (GDP)
Keen to details
Excellent English skills in both oral and written

医药