Davipharm

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 recruitment@davipharm.info