1. Familiar with and be able to use the test instrument/equipment involved in the validation process to perform the test activities; be responsible for the collation of the test data, statistical calculations, and the preparation of validation reports;
2. Execute the company's project management process, coordinate internal and external resources, and manage the implementation of the validation of the project;
3. Responsible for the summary and continuous follow-up of the relevant regulations and guidelines for his or her professional field, including but are not limited to major GMPs in China and abroad, the regulations and guidelines of PDA, ICH, ISO, national standards and relevant domestic and international industry standards, to ensure that the validation standards and methods of his or her profession are in the cutting edge of the pharmaceuticals industry.
1. Bachelor degree or above in pharmaceutical, chemical, analytical, biological and other related fields;
2. More than 3 years working experience in pharmaceutical factory, more than 1 year experience in his or her professional validation of pharmaceutical companies; experience in the complete commissioning and validation of the equipment/system of the new projects in his or her professional is preferred; validation experience in the standard projects related to the EU, FDA, WHO and other standards is preferred;
3. Be able to lead the team to perform the professional equipment/system commissioning is preferred.
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