About the role The incumbent will be part of a larger team within the Logistics department in providing seamless and customer-focused solutions to support the achievement of business objectives. What you will be doing QMS Maintenance and Administration
Ensure proper administration of QMS for the facility in accordance to the procedure
Maintain up to date master lists and proper control of all released QMS documents
Process owner of Quality-related SOPs and conduct regular reviews in accordance to procedure
Collaborate with Operations to ensure proper review of operational SOPs and continuing compliance with all applicable regulatory requirements e.g. PIC/S GMP guide and customers\xe2\x80\x99 quality requirements
Review and approve all work-related materials for display on the Healthcare site
Ensure handling of pharmaceutical products adheres to QMS and IATA requirements.
QMS Training and Development
Prepare and administer relevant SOP, Quality and GMP refresher training for Healthcare Hub staff
Ensure that training records for all staff in the Healthcare Hub are maintained and up to date
Ensure appropriate administration and execution of structured training programme for all work functions in collaboration with Operations
Supplier Assessment
Assess new suppliers according to the procedure
Equipment/System Qualification, Calibration and Maintenance
Ensure proper management of equipment/system qualification and validation according to the relevant requirement
Ensure that the environmental monitoring, pest control, cleaning, and equipment maintenance are performed and documented as per requirement and procedure
Conduct quality review to ensure equipment calibrations/preventive maintenance are done per the stipulated frequency in the procedure
Internal Audits (Self-Inspection)
Lead, plan and perform periodic internal audits in accordance to the relevant procedure
Prepare and submit report to the Head of Department for review and approval
Deviation, Complaints and C/PA Management
Designated person to handle deviation, product complaints, product recall and return, in collaboration with Operations, ensuring that investigations and C/PAs are implemented and closed out appropriately
Batch Release
Authorized person to perform Batch Release for repackaged medicinal products according to the procedure and ensuring that all relevant regulatory and GMP requirements are complied with.
Product Quality Review
Designated person to perform product quality review according to the procedure
Requirements The successful candidate
Diploma/Degree in Science or related field
Minimum 1 year of Quality working experience
Proficient in MS Office
Good team player with good communication and interpersonal skill
Ability to multi-task and work independently
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