職位招聘

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Regulatory Affairs Assistant / Officer

Support timely compilation and submission of dossiers for approval of product registration, change of particulars and renewal, communicate with Support timely compilation and submission of dossiers for approval of product registration, change of particulars and renewal, communicate with Department of Health and respond to their queries, provide regulatory support to internal departments.

Key Roles and Responsibilities

  • Support timely compilation and submission of dossiers for approval of product registration, change of particulars and renewal
  • Communicate with Department of Health and respond to their queries
  • Provide regulatory support to internal departments
  • Assist in ad-hoc projects assigned by Q.A Manager

 Qualification and Experience

  • Higher Diploma, Associate Degree or Degree holder in science, pharmacy, pharmaceutical or related disciplines
  • With good communication skills, hard-working, willing to learn
  • Good communication skills in both written and spoken English and Cantonese
  • Relevant work experience is preferred but not essential

Fresh graduates are welcome 

Other related:

Validation Engineer (Quality Executive)

Define and plan validation activities to meet the cGMP requirements, coordinate with end users and process owners to develop and execute validation protocols for manufacturing facilities, systems, process and/or software; analyze validation related issues, implement validation related event, Change Control and CAPA.

QC Technician

Sampling and testing of raw materials, packaging materials, purified water, in-process samples, finished products and stability studies samples, operation of laboratory equipment, assisting in laboratory equipment calibration, qualification and maintenance.

QC Officer / Assistant QC Officer

Prepare and revise QC SOP and GMP documents, assist in implementing and maintaining the documentation system, prepare validation and qualification documents, conduct product quality review, develop QC training program.