– 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 analyses 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.
– Other ad-hoc assignments from direct supervisor.
– At least 2 years of experience in the same position.
– Knowledge of pharmaceutical law, GMP requirements, manufacturing processes, testing process, validation
– Knowledge of 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 the risk assessment.
– Understand the systematic process of WHO GMP, EU GMP in the pharmaceutical industry.
– Can communicate in English
Lot M7A, D17 street, My Phuoc 1, Thoi Hoa, Ben Cat, Binh Duong
For more information please email to email@example.com with the email title: “Validation Specialist”.