Quality Assurance Officer

3 days ago


Hong Kong, Central and Western District, Hong Kong SAR China Hong Kong Regen Medtech Limited Full time

On-site Full Time 2 year or below Entry level

Skills:

Biotechnology

Job Responsibility

  • Assist QA Department's daily operations.
  • Prepare cleanroom / utilities / equipment DQ/IQ/OQ/PQ protocols and reports, and various validation Protocols and reports.
  • Prepare initial assessment of Product Quality Review and Management Review Reports and submit to Authorized Person and management.
  • Prepare 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/or management team.

Qualification and Experience

  • Bachelor's degree or above in biotechnology, biochemistry, chemistry and medical laboratory science or science degree with relevant to cell therapy, gene therapy, regenerative medicines or tissue engineering, or other similar sciences disciplines;
  • 2 years of experience in quality assurance role in pharmaceutical GMP environment is preferred
  • Knowledge of PIC/S GMP and other quality system / quality assurance principles is highly preferred.
  • Received formal training on Quality Management System e.g. ISO 9001 Internal Auditor is highly preferred.
  • With knowledge and/or experience in GMP operations of sterile pharmaceutical products, biological substances or products, or cell-based products is highly preferred.
  • Excellent communication, problem-solving, time management and prioritization skills.
  • Self-motivated and a good team player, attention to details.
  • Proficiency in English and Chinese.
Additional Information Job Level

Entry level

Publish Date

04/03/2025

Job Ref. No.

N/A

Job Function

Quantity Surveying / Quality Assurance

Company Overview

Hong Hong Regen Medtech Limited ("HKRM") is a newly established stem cell biotechnology company dedicated to developing regenerative medicine for intractable diseases. Through harnessing the therapeutic potential of stem cells, HKRM is developing new medicine targeting degenerative and immunological diseases. HKRM engineered stem cell manipulation and differentiation platform mimicking native developmental niches to generate high-quality cell therapy products.

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