QC Associate (Pharma | Jurong | 1 year Contract) JOB PURPOSE
Carry out system validation and qualification of laboratory instruments and equipment in compliance with regulatory standards, site SOP's and test procedures. Shall ensure that all activities meet quality, cGMP, Health, Safety and environmental standards. Assist in other functions such as documentation, and preparation of standard operating procedures. REPORTING RELATIONSHIP
The job holder reports to the QC Supervisor (System). KEY ACCOUNTABILITIESParticipate in the Daily Capacity Management and +QDCI Level 1 sessions to ensure that site and department KPI's are met. Assist in carrying out on-the-job training to other QC analysts, by incorporating cGMP and safety aspects of the procedures. Assisting QC Supervisor (System) to ensure that systems, critical methods etc. setup within the analytical section complies with cGMP requirements regulatory requirements, corporate policies, compendial and site SOP's. Assisting the QC Supervisor (System) in analytical instrument / equipment lifecycle management through implementing appropriate QC systems, selection of appropriate lab equipment for purchase through authoring and documentation of details URS, involve in instrument / equipment qualification, reporting, drafting and implementing SOP's for system operation and maintenance, monitoring performance of the equipment, decommissioning of equipment. Shall assist QC Supervisor (System) in maintaining the asset register for equipment, CS Inventory, Excel Sheet inventory used in the QC lab. Carry out analytical testing for Raw Material, Intermediates, Finished Product (if required) in compliance with specifications, analytical test methods, laboratory methods and pharmacopoeial requirements. Assist in carrying out maintenance / calibration records of laboratory instruments / equipment in compliance with established schedules. Assist in improving and maintaining test methods and equipment (i.e. qualification, validation and transfer). Participate actively in efficiency management of the laboratory and contribute towards continuous improvement through teamwork, feedback and collaboration. Maintenance of specifications, lab methods, standard operating procedures and other GMP documents in the lab. Responsible for electronic raw data handling in compliance with regulations and guidelines Participate in regulatory inspection and customer audits preparedness at site with regards to cGMP Quality and HSE aspects. Ensure compliance with HSE and quality policies and site procedures. 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:
- Familiar with analytical testing methods
- Must be analytical, methodical and quality conscious.
- Knowledge of FDA regulations and cGMP will be desirable
- Possess good interpersonal skills
- Diploma in Chemical Process Technology / Bio-Process Technology' with minimum 5 years' experience; of GCE 'A'/'O' level with minimum of 8 years relevant experience.
If you have the relevant skillsets, please send in your updated CV in word format to [Click Here to Email Your Resume]
We shall contact shortlisted candidates.
Ng Yew Koon Sherry
Senior Recruitment Consultant (R1657259)
Sherry, Yew Koon Ng EA License No.: 02C3423 Personnel Registration No.: R1657259