Assist QC Manager to establish the new chem. lab and maintain the routine operation of chem. Lab
Prepare, review and updated related SOPs, test method and specifications
- Prepare the qualification protocol, conduct the qualification activities for equipments and complete the qualification report, such as IQ/OQ/PQ or re-qualification for chem. Lab equipment.
- Participate the technical transferring ，conduct the analytical method transferring work and complete the analytical method transferring report
- Prepare the analytical method validation/verification protocol, conduct the related testing and finish the validation report, such as process validation, cleaning validation, pharmacopeia test method verification etc.
- As local administrator of laboratory computerized system, Clean， maintain the equipments and contact with supplier or proper contractor to qualify/calibrate the equipments to keep in good status.
- Assist in As administrator of reagent and reference standard, management of chemical lab consumables, including reagents, reference standards, glassware, PPE etc..
- 复核检验记录，必要时协助OOS 调查
- Perform analytical record double checking and assist in OOS investigations when necessary.
- Prepare the new staff training plan and qualification plan for new staff and conduct the training.
- 协助SHE 管理，确保试验室各项活动符合公司SHE 的政策
- Assist in SHE management to keep the lab to be in conformity with company SHE policy.
- Complete other assigned tasks
- GMP 符合性
- GMP compliance
- Follow related SOPs and regulations strictly in chemical lab.
- 及时按照SOP 的要求填写相关文件记录如批化验记录、仪器使用和维护记录等并保证内容的准确性
- Fill in related documentation such as BAR, other logbook etc., timely to ensure the accuracy of content as per requirement of SOPs.
- Take part in actively in correction to the observations found in self-inspection.
- Have basic analytical chemistry knowledge and set high goal to improve professional skills to meet the requirement as ainternational role; receive continuous training to explore new analytical areas.
- Customer focus
- Make both internal and external customers and their needs a primary focus of one’s actions; develop and sustain productive customer relationships.
- Team work
- Show strong willingness to work closely with peers within own unit or colleagues from other unitstoward a common goal.
- Result oriented
- Establish stretched goals for organization successand personal accomplishments; strive to meet or exceed those goals.
- Learning /adaptability
AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.