Quality Control Associate

3 days ago

Singapore CIELO TALENT PTE. LTD. Full time

JOB PURPOSE

To carry out the tasks mentioned in this Job Description in compliance with standard operating procedures, protocols, laboratory and analytical test methods ensuring quality, cGMP, Health, Safety and environmental standards

KEY ACCOUNTABILITIES

1.Participate in the Daily Capacity Management and +QDCI Level 1 sessions to ensure that site and department KPI’s are met.

2.Assist in carrying out on-the-job training to other QC analysts and chemical technicians, by incorporating cGMP and safety aspects of the procedures.

3.Shall be responsible to manage stability studies for all products manufactured at site which involves protocol revision, inception of stability samples for stability program, planning for stability sample pull out on a monthly basis, co-ordinate with analysts and prioritization of testing, preparation of stability summary results and annual stability report, arrange monthly stability meeting for updates and follow up, management of stability chambers and other related aspects of stability testing

4 Will be responsible to author investigation reports for laboratory investigation (ILI) and deviations, lead and oversee investigation in the laboratory.

5.Carry out analytical testing for Finished Product, Intermediates, Raw Material (if required) in compliance with specifications, analytical test methods, laboratory methods and pharmacopoeial requirements.

6.Carry out analytical results and audit trail review when required.

7. Assist in carrying out maintenance / calibration records of laboratory instruments / equipment in compliance with established schedules and review of the maintenance records.

8.Assist in improving and maintaining test methods and equipment (i.e. qualification, validation and transfer).

9.Maintenance of specifications, lab methods, standard operating procedures and other GMP documents in the lab.

10.Source for reagents/laboratory consumables by keeping in view the department budget targets.

11.Participate actively in efficiency management of the laboratory and contribute towards continuous improvement through teamwork, feedback and collaboration.

12.Participate in regulatory inspection and customer audits preparedness at site with regards to cGMP Quality and EHS aspects. 13.Report and trend test results (Annual Product Review - APR)

14.Review and maintain all required laboratory documents (i.e. raw data sheets, log books).

15.Ensure compliance with HSE and quality policies and site procedures. Ensure safe working in the laboratory by practicing and communicating safety.16.Other responsibilities that are not included in the above but are related to quality control and in accordance to internal guidelines and SOP

Job Requirements

1. Diploma in Chemical Process Technology / Bio-Process Technology’ or GCE ‘A’/’O’ level with relevant experience will also be considered.

2. Must be analytical, methodical and quality conscious.

3. Knowledge of FDA regulations and cGMP will be desirable

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