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Assistant Officer – Quality & Regulatory Affairs

Assistant Officer – Quality & Regulatory Affairs

KLN Pharma (Hong Kong) LimitedHong Kong
18 days ago
Job description

Responsibilities

  • Assist to perform and maintain QA activities and records for product release, product return and repackaging to ensure the compliance of GMP, GDP, and regulatory requirements
  • Assist to coordinate and execute process validation; prepare documentations, policy, protocol and report
  • Assist in establishing and maintaining quality management system and an efficient pharmacovigilance system in compliance with the local authority’s regulation and Regional PV policies & SOPs
  • Provide support in the GMP (repackaging) operation including incoming materials inspection, in process control and finish product sampling
  • Support regulatory affairs / product registration related activities
  • Process documentation of corrective actions plans and monitors implementation;
  • Participate ad hoc project as assigned

Requirements

  • Bachelor degree or above in related scientific discipline
  • 1-2 years of relevant QA experience in food / healthcare products / pharmaceutical industry is preferred;
  • Knowledge in ISO, GDP, GMP and QMS is an advantage
  • Strong team player, can-do attitude, detail minded, eager to learn, high self-driven to exceed expectations and take up more challenges
  • Good command of both written and spoken English and Chinese, including Mandarin
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    Assistant Officer • Hong Kong