Licensed Pharmacist

Insight Connect Solutions Inc.

HK$4.6-5.3K[月薪]
现场办公 - 達義1-3 年經驗本科全職
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職位描述

福利待遇

  • 法定福利

    13薪, 員工貸款, Pag-Ibig 基金, 菲爾健康, SSS/GSIS

  • 職業發展

    工作培訓

  • 休假和請假

    產假和陪產假, 病假, 單親假, 休假

  • 工作生活兩不誤

    居家辦公

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Regulatory Compliance:

  • Ensure company operations and products comply with the rules and regulations of the Philippine FDA. -
  • Monitor updates and advisories issued by the FDA and ensure immediate company-wide implementation.
  • Prepare and submit compliance reports and documentation to the FDA.

Licensing and Registration

  • Oversee the application and renewal of FDA licenses such as LTO (License to Operate), CPR (Certificate of Product Registration), and other necessary permits for pharmaceuticals, cosmetics, food, and medical devices. - Maintain up-to-date records of all regulatory filings and certificates.

Audit and Inspection Handling:

  • Prepare the company for routine and spot inspections by FDA officers. - Serve as the point person during FDA audits and respond to FDA findings or notices

Documentation and Record Keeping

  • Maintain comprehensive and accurate documentation of all compliance-related activities. - Ensure traceability and document integrity for all FDA-regulated products.

Internal Training and Policy Development

  • Educate staff and departments on FDA regulations and compliance protocols.
  • Develop internal SOPs (Standard Operating Procedures) based on regulatory guidelines.

Adverse Event and Recall Management

  • Monitor and report adverse drug reactions or product complaints to the FDA as required.
  • Coordinate product recalls in case of FDA-mandated withdrawals or safety issues.

Liaison with Regulatory Authorities:

  • Communicate effectively with FDA personnel and other government agencies. - Ensure timely submission of queries, appeals, and supporting documents.
  • 2-3 years experience with FDA & BAI regulatory application
  • Fresh Graduates are welcome to apply
  • Licensed Pharmacist required
  • Good communication skills
  • Must be willing to work on-site at BGC Taguig
  • Can start ASAP
英語語言製藥規劃
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de Belen MJ

HR/Admin ExecutiveInsight Connect Solutions Inc.

今天回覆 0 次

工作地址

24th, The Philippine Stock Exchange, Inc.. PSE Tower, 5th Avenue corner 28th Street, BGC 1634, Taguig, Philippines

發布於 02 July 2025

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