职位描述：
job description:
- review and approve project engineering documents such as commission and qualification documents.
- review and approve validation documents such as validation protocols, test records and reports.
- review and approve all sops and other appropriate quality related documents.
- review production batch manufacturing record and lab control records. involve in the product release.
- deviation investigation and control.
- change request management.
- investigate quality related complaints.
- manage the capa actions.
- involve the oos investigation.
- conduct the product quality review.
- review and approve the critical equipment maintenance and calibrationplanand records.
- conduct the internal audits.
- make sure the training system efficient and conduct the gmp training.
- supplier audit and approval.
- review and release raw materials, intermediates, packaging and labelling materials.
- document management.
- monitoring the quality kpis.
- any other works designated by the company.
qualification:
- at least 7 years quality experiences in pharmaceutical industry, international biopharma company preferred.
- university education with relevant majors such as pharmacy, chemistry etc. master degree preferred.
- fluent written and spoken english.
- team spirit.