Validation Specialist

Job description

  • Development of validation documentation, validation part of registration documentation, development of User Requirements Specification (URS) documents.
  • Organizing and timely performance of validation work in the range of validation / qualification of devices, systems, installations, computerized systems, validation of production processes, cleaning methods for each employee in the area of his activity.
  • Development of validation tests based on performed risk analysis, including:
    a) Evaluation of the performed analysis, evaluation of the results of the validation / qualification work and defined final conclusions.
    b) Open change control for recommendations described in protocols / reports of validation / qualification of equipment, systems and installations, validation of computerized systems, production processes, cleaning method for each employee within the scope of their activity.
  • Participation in the acceptance of devices, installations and systems that require validation / qualification works.
  • Supervising the current status of validation documentation in the scope of its activities.
  • Participation in the investigation of deviations and complaints, ensuring their efficient and timely implementation in accordance with the implemented procedure, used the Problem Solving tools.
  • Participation in the 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.
  • Implementation and monitoring of quality process improvement indicators and ensuring their implementation.
  • Participation in the change control process in the range of the Validation System.
  • 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.
  • Performing internal audits at Davipharm and external audits at contractors’ production sites/ offices to ensure the quality system and quality of Davipharm products.
  • Do other ad-hoc assignments from direct supervisor.

Job requirement

  • Pharmacist, Engineer, Bachelor, Intermediate pharmacist.
  • 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 in the scope of validation works.
  • Knowledge of the equipment used in the pharmaceutical company.
  • Knowledge of pharmaceutical processes in production areas.
  • Knowledge of statistical analysis.
  • Ability to perform risk assessment.
  • Ability to analyze and solve problems.
  • Understand the systematic process of WHO GMP, EU GMP in the pharmaceutical industry.
  • Good communication by English skills.

Please contact our Recruiter or apply via email