Stability Study Team Leader

Job description:

  • Supervision over the process of preparing and conducting stability study for pharmaceutical products. Assessing the functioning of the quality system in this stability study process
  • Supervision over the process of preparing and conducting storage conditions for stability samples
  • Preparation and supervision over the process of preparing and conducting of the stability study schedule according GMP requirements
  • On-time preparation of stability protocols and stability reports
  • Organization, implementation and improvement of the Pharmaceutical Quality System. Controls and assessment of the functioning of the stability study process in Davipharm
  • Participation in the deviation and 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
  • Establishing indicators for the improvement of quality processes and ensuring their implementation
  • Implementation of designated projects for the development of the Pharmaceutical Quality System in Davipharm
  • Coordination of activities leading to compliance with GMP requirements

Job requirement:

  • Master’s degree/ Engineer/Bachelor’s Degree in pharmacy/Chemistry/ Biology
  • 3-5 years of experience as a QA specialist
  • Knowledge of pharmaceutical quality system, pharmaceutical law, GMP requirements, manufacturing processes, testing process, validation
  • Excellent knowledge of the implementation of Pharmaceutical Quality system
  • 2-3 years of experience in pharmaceutical factory (QC, QA area)
  • Ability to analyze and solve problems
  • Ability to work under pressure hight and intensive deadlines
  • Understand the systematic process of WHO GMP, EU GMP in the pharmaceutical industry
  • English – intermediate level

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