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1、Establish and improve the material, cell and finished product release process to ensure that the material, cell and finished product release meets the established quality standards and GMP requirements.
2、Responsible for the pre-release review, organization, filing and borrowing of records such as batch production records, intermediate control records, batch inspection records, etc.
3、Responsible for the collation of material, cell and finished product release packages, including associated deviations, changes, etc.
4、To interface with the warehouse on the release of materials, cells and finished products according to the release conclusion of the quality delegate or its subdelegate, and to convert the quality status mark from pending inspection to qualified or unqualified.
5、Participate in official and/or third-party audit activities of the company, cooperate in providing metrology-related documents and records during audits, and provide answers when necessary.
6、Complete other work assigned by the supervisor.
1、Bachelor degree or above, majoring in pharmacy or biology
2、Have more than 2 years working experience in pharmaceutical companies, understand the supervision and release of biologics production site related work
3、Familiar with the operation of word, excel and other common office software.
4、Have basic English reading and writing skills.
5、Strong comprehensive judgment ability, strong communication skills, teamwork ability and good professional ethics and dedication.