Quality Compliance Specialist

Career
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Job description:

  • Developing, reviewing and approving documentation in quality system.
  • Performing internal trainings of procedures system and guidelines of the Pharmaceutical Quality System.
  • Participation in the change control process, opinion changes in the range 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, included trend analyzes and defining appropriate actions.
  • Do other ad-hoc assignments from direct supervisor

Job requirement:

  • Pharmacist or Engineer pharmacy field
  • At least 1 year of experience in the same position in pharmaceutical factory
  • Knowledge of pharmaceutical law, GMP requirements, manufacturing processes, testing process, validation.
  • Knowledge of Pharmaceutical Quality system
  • Ability to perform risk assessment.
  • Ability to analyze and solve problems.
  • Ability to work under high pressure and intensive deadlines
  • Understand the systematic process of WHO GMP, EU GMP in the pharmaceutical industry
  • MS Office 365: Microsoft Excel, Word
  • Good command of English skills

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