Assistant Engineer, QC

3 weeks ago


Qingdao, Shandong, China AstraZeneca Full time

Responsibilities:


• Finish the routine analytical work accurately and timely


• Conduct the maintenance and validation for instrument periodically based on plan and keep it in good status.


• Double-checking the BAR.


• Responsible for the management of chemical reagents/ reference standard/ consumables, including purchase and maintenance of safety inventory


• Responsible for the handling and disposal of lab wasted articles/expire reagent/toxic substances


• Keep the chemical lab tidy and clean at any time.


• Report any deviation timely and assist in investigation


• Stability study and test


• Equipment & Column routine maintenance


• Issue and revise specification, test method and batch analysis record of starting materials and finished products, and purchasing specification, test method for PQ, CQ etc.


• Prepare specification for application (draft) and specification explanation


• Check specification and test method for import products together with Regulatory department


• Maintenance of QC E-system eg. GQCLIMS, E-lab, Empower


• Technology transfer and method validation/verification


• Follow related SOPs and regulations strictly in chemical lab.


• 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.


• Participate actively in serials training required to be held by internal and external.


• Develop all kinds of skills in relation to work field and pursue continuous improvement


• Coach the new employee and carry out training to them.


• Update of SOPs when required.


• Assist in engineer's works when required.


• Finish other work assigned by group leader

Requirements:


•University or above
•Basic GMP, GLP knowledge; Experience in QC
•More than 5 years working experience in pharmaceutical company or related industry
•Good English command
•Good computer skill
•Good team work spirit

Date Posted

17-6月-2024

Closing Date

30-7月-2024
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