QC Lab Analyst (Tuas/ Night Shift/ Contract)

Our client is a global biopharmaceutical company focused on human health.

Job Purpose

Reporting to QC Chemist, the incumbent will carry out QC analyses in compliance with Laboratory and Analytical Methods ensuring quality, cGMP, heath, safety and environmental standard are met. Assist in other functions such as documentation and preparation of standard operating procedures.

Responsibilities

• Assist in carrying out on the job training of other QC Analysts, incorporating cGMP and safety procedures.
• Perform and carry out analytical testing in compliance with specifications, Analytical Methods, Laboratory Methods and pharmacopoeia requirements.

• Assist in monitor the calibration and maintenance program for laboratory instruments / equipment and ensure compliance with established schedules.
• Assist in qualification of laboratory equipment and validation of analytical methods.

• Ensure that analyses are carried out and reported in accordance with GLP (Good Laboratory Practices). Ensure that analyses are completed on time and are consistent with business requirements.
• Assist in conducting OOS and atypical results investigation.
• To ensure that qualification, preventive maintenance and calibration of laboratory equipment are carried out.
• Report and trend test results.

• Planning and assurance of cGMP compliant quality testing and documentation according to schedule.
• Prepare laboratory reagents in compliance with GLP and laboratory SOP requirements. Source reagents / laboratory consumables keeping in view department budget targets.
• Assist in other functions such as preparation of standard operating procedures and Assist documentation etc and participate in departmental activities as and when required. Maintenance and development of all required laboratory documents (i.e. raw data sheets, log books).
• Responsible for electronic raw data handling in compliance with regulations and guidelines.
• Responsible for inspection and audit preparedness with respect to cGMP and EHS issues.
• Ensure safe working in the laboratory by practicing and communicating safety.
• Other responsibilities that are not included in the above but are related to quality control and in accordance to internal guidelines and SOP

REQUIREMENTS

• Possess minimum of 3 years' hands-on experience in similar capacity.
• Must be willing to work permanent night shift.
• Good knowledge of FDA regulations and cGMP.
• Must be analytical, methodical and quality conscious.
• Must be resourceful, conscientious, dedicated and a good team player
• Possess good interpersonal skills.
• Preferably possess a Diploma in chemistry/ chemical process technology / bio-process technology; or a ITE graduate.

If you have the relevant skillsets, please send in your updated CV in word format to sherry.ng@manpower.com.sg.

We regret only shortlisted candidates would be contacted.

Sherry, Yew Koon Ng EA License No.: 02C3423 Personnel Registration No.: R1657259