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Regulatory Pharmacist

BEACONS PHARMACEUTICALS PTE. LTD.
  • Job Category
    Healthcare / Pharmaceutical, Manufacturing, Sciences / Laboratory / R&D
  • Job level
    Executive
  • Contract type
    Contract
  • Location
    West
  • Salary
    S$3500 - S$4500

Job Description

MAIN FUNCTIONS:

  • Form A license holder and other license as required by regulatory.
  • Liaise with regulatory body regarding pharmaceutical compliance affair.
  • To update local and overseas countries on regulatory requirement for implementation.
  • Involved in day-to-day pharmaceutical manufacturing operations and ensure compliance to PIC/S GMP standard.



RESPONSIBILITIES:

  • To assist in maintenance of product license with local and overseas authority.
  • To prepare product registration dossier for local and overseas market.
  • To assist in regulatory audits and response to the authority query.
  • To assist post-marketing product query or correspondence and work closely with QA/QC department pertaining to product quality issue.
  • Responsible for all dispensing materials and activities to use in production.
  • Maintenance of controlled drugs and records, including the storage and sale.
  • Review and update SOP relating to the production periodically.
  • Handling and managing of production issue raised by the production team.
  • Provide training to production staff on SOP and cGMP.
  •  Work closely with QA/QC department to maintain cGMP standard.
  • Be involved in other company projects.



REQUIREMENTS:

  • Candidate must possess at least Bachelor's Degree of Science (Pharmacy).
  • At least 2 Year(s) of working experience in the related field is required for this position.

Closing on 07 Mar 2021