SUMMARY OF ESSENTIAL FUNCTIONS
- To support the execution of effective Quality Management System. Ensure clinical storage, secondary assembly/ packaging and distribution activities comply with applicable Quality standards (Good Manufacturing Practices and Good Distribution Practices).
- Execute quality procedures and related inspection/ release activities.
- Manage and participate in new material qualifications, execution of inspection activities, preparation of inspection reports, as applicable.
- Oversee and ensure non-compliance materials are maintained in the appropriate lot status in the inventory system and proper storage locations.
- Ensure retention samples, blinding samples, and printed labels are accounted for.
- Review and approve the label print request, if applicable.
- Support and manage both the Product Incoming and In-process inspection activities conform to the requirements prior to release activities.
- Track incoming materials performance indicators and establish trend analysis (where necessary) for quality improvement initiatives.
- Support and participate in Quality Management Review when needed. Audit Activities
- Plan and execute internal audit/ self-inspection in accordance with written procedures. Ensure selfinspections are completed within the timeline.
- Co-host or participate in external audit activities, e.g. Regulatory, customers and supplier audits/ inspections. Quality Management System
- Escalate and report non-compliance practices and activities for corrective and preventive actions.
- Support review and approval of Change Control, Customer Complaints and Deviations, CAPA and Risk Assessments.
- Initiate Change Control, Customer Complaints and Deviations, CAPA and Risk Assessments associated with Quality Operations.
- Review and approve site procedures. Ensure written procedures comply with applicable regulations and guidelines.
- Author procedures related to site Quality Operations, as applicable.
- Ensure document retention and archival activities are executed in accordance with written procedures.
- Ensure site procedures are aligned with corporate policies. Validation
- Participate and support qualification/validation activities. Training
- Ensure timely completion of training activities assigned, both local and global SOPs.
REQUIREMENTS
- Min Degree / Diploma preferably in Pharmaceutical or Science disciplines.
- Min 5+ years’ experience in quality functions in Pharmaceutical/ Healthcare organization
Salary range: $5K to $6K
Pharma Supply Chain MNC
Interested candidates, please forward your resume to [email protected]
Consultant: Huang Jingsheng Kevyn (R1333338)
Recruit Express Pte Ltd (99C4599)
