Quality Assurance Lead

2 weeks ago

Hong Kong, Central and Western District, Hong Kong SAR China Chemill Pharma Ltd. Full time
Job Description

The Quality Assurance Lead will be responsible for implementing and maintaining quality systems to ensure compliance with local and international regulations.

Main Responsibilities:

  • Implement and maintain the pharmacovigilance system to ensure compliance with local and international regulations.
  • Develop and implement regulatory strategies to ensure compliance with local and international regulations.
  • Manage regulatory submissions and communicate with health authorities to ensure timely approvals.
  • Conduct product quality risk assessments and develop risk management plans.
  • Lead the preparation and submission of regulatory dossiers for new products, variations, and renewals.
  • Provide regulatory guidance and support to cross-functional teams.
  • Ensure compliance with adverse event reporting requirements and manage pharmacovigilance activities.
  • Manage quality-related investigations, deviations, and CAPAs to ensure timely resolution.
  • Prepare and conduct internal and external quality audits to ensure compliance with regulatory requirements.

Requirements:

  • Bachelor's degree in pharmacy or related field. Advanced degree is a plus.
  • Minimum 3 years of experience in regulatory affairs, quality assurance, and pharmacovigilance in the pharmaceutical industry.
  • Strong knowledge of local and international regulatory requirements and guidelines.
  • Experience in managing regulatory submissions and interactions with health authorities.
  • Familiarity with GMP, GDP, and other relevant quality standards.
  • Experience in managing pharmacovigilance related regulations and adverse event reporting.
  • Strong analytical, problem-solving, and project management skills.
  • Excellent communication, interpersonal, and leadership skills.
  • Fluent in English and Chinese (Cantonese and Mandarin).
  • Ability to work independently and in a team environment.

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