Quality Compliance Specialist

Job description

  • Developing, reviewing and approving documentation in quality system.
  • Performing internal trainings on procedures and guidelines in the Pharmaceutical Quality System.
  • Participation in the change control process in the scope of the Quality Compliance System.
  • Performing internal audits at Davipharm and external audits at contractors’ production sites/ offices to ensure the quality system and quality of Davipharm products.
  • Performing internal audits / external audits.
  • Performing qualification for manufacturers/ suppliers/ service
  • Preparation and updating the Quality Agreements with manufacturers/ suppliers/ service
  • Implementation of system activities in accordance with the guidelines and quality risk management
  • Participation in the corrective and preventive actions (CAPA) to ensure the effective and timely implementation in accordance with the implemented procedure, including initiation of actions to prevent non-compliance.
  • Participation in the investigation of complaints, ensuring their efficient and timely implementation in accordance with the implemented procedure. Assessment of the impact of the complaint on the product on the market.
  • Implementation of designated projects for the development of the Pharmaceutical Quality System in Davipharm
  • Participation in the periodic Product Quality Review, including trend analysis and defining appropriate actions.
  • Do other ad-hoc assignments from direct supervisor.

Job requirement

  • Bachelor’s degree or College of Pharmacy
  • At least 1 year of experience in pharmaceutical factory.
  • Knowledge of pharmaceutical law, GMP requirements, manufacturing processes, testing process, validation.
  • Knowledge of Pharmaceutical Quality system
  • Ability to perform risk assessment.
  • Understand the system and process of WHO GMP, EU GMP in the pharmaceutical industry.
  • Good command of English.

Please contact our Recruiter or apply via email tam.thaithanh@davipharm.info