Assistant Engineer, QC
6 months ago
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 spiritDate Posted
17-6月-2024Closing Date
30-7月-2024-
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