• Ensure that analytical equipment are maintained and calibrated accurately and timely in accordance to site procedures, CAP and regulatory requirements.  
• Lead and/or participate in investigations arising from laboratory equipment/computer systems events and propose effective CAPA to minimize reoccurrence.         
• Perform periodic validation review of systems /laboratory equipment in a timely manner to ensure that the validation status is maintained, and make recommendations for re-validation as required    
• Lead or participate in laboratory equipment validation in accordance to site procedures and regulatory requirements, inclusive of writing, reviewing and approval of validation related documentations
• Maintain and support computer systems and laboratory equipment according to site change control and access control procedures.      
• Perform accurate and thorough impact assessment on laboratory equipment, systems change control to ensure all impacted areas are adequately assessed and impacted documentation are updated in a timely manner.   
• Revise, review and maintain laboratory procedures, instructions, methods to ensure compliance with regulatory, QMS, CAP and pharmacopoeia.         
• Ensure a safe working environment in the laboratory and perform 6S inspection. 
• Supervise, develop and motivate team members and other assigned staff to help realize their maximum potential so as to contribute towards achieving the objectives of the department.      
• Conduct effective training for laboratory staff on computer systems/equipment and relevant procedures.
• Ensure regulatory compliance, perform Level 1 audit and support L2 / L3 / L4 audits       
• Ensure timeliness and accuracy of Pharmacopoeia & CAP review           

Requirement:

• Min. Science degree holder with experience in the field of Chemical, Pharma or Manufacturing industry
• Good knowledge of GMP and laboratory equipment/validation
• Good knowledge of quality, laboratory techniques and laboratory compliance
• Good knowledge of regulatory expectations /CAP/ICH requirements
• Good knowledge of analytical equipment capabilities and operational needs

GMP Technologies (S) Pte Ltd   |   EA Licence: 11C3793   | EA Personnel:  Fiona Koh  |   Registration No: R1109239