Job Details
  • Reference237242_1629451423
  • Location
  • SalaryNegotiable
  • Job TypeFull Time
  • Postedabout 1 month ago
  • ConsultantAdel Leung
  • Consultant emailEmail Adel

Job Responsibility

  • Responsible for organizing and progress monitoring of QA Department's daily operations.
  • Approval of cleanroom / utilities / equipment DQ/IQ/OQ/PQ protocols and reports, and various validation Protocols and reports.
  • Perform initial assessment of Product Quality Review and Management Review Reports and submit to Authorized Person and management.
  • Be a key member in conducting self-inspections and external audits.
  • Provide coaching and training to QA staff, and advanced training on GMP and aseptic operation topics.
  • Approval of SOPs related to QA Department.
  • Plan and provide practical and compliant solutions in change controls, deviation investigations, OOS investigation, CAPA, quality risk assessments, qualification and validation, supplier evaluations, and continual improvement.
  • Raise quality issues to the Authorized Person and management in a timely manner.
  • Work with the Authorized Person to develop and monitor quality KPI.
  • Other duties as assigned by Authorized Person and management.

Preferred Qualification and Experience

  • A holder of a bachelor's degree in Life Science discipline such as biotechnology, biochemistry, chemistry and medical laboratory science, with at least 8 years of work experience.
  • At least 4 years of experience in quality managerial role in pharmaceutical GMP environment.
  • Proficiency in English and Chinese, and computer skills.
  • Knowledge of PIC/S GMP and other quality system / quality assurance principles.
  • Preferably received formal training on Quality Management System e.g. ISO 9001 Internal Auditor or Lead Auditor.
  • With knowledge and/or experience in GMP operations of sterile pharmaceutical products, biological substances or products, or cell-based products.
  • Attention to details.
  • Excellent communication, problem-solving, time management and prioritization skills.
  • Self-motivated and a team player.