Title:  Executive Quality Assurance

Job Summary

• Lead in Quality Operations (QO) on Controlled Drug process.

- To manage all the required QA inspections, controls and verifications for Controlled Drug to ensure compliance of warehousing processes from inbound to outbound to SOP/ WI, clients’ and /or regulatory requirements

- To verify quality defects / quarantined products.

- To perform self-inspection / pre-audit and follow up with process

  owner to close all observations.

• Handle Change Control management.
• Manage Product Quality Complaints (PQC)
• Back up for Manager, Quality Assurance on area as assigned during his/her absence 

General Responsibilities

Change Control Management 40%                                                                         

• To maintain an updated Change Control Masterlist.
• To assure timely management of Change Control and completion of related reporting requirements

Compliance of Warehousing Processes 20%                            

Perform QA verification according to respective SOP/WIs for Controlled Drugs processes:

• Inbound – Redressing, Receiving
• Storage / bin integrity – product segregation, status labeling, product traceability
• Outbound – delivery, Reject Upon Delivery (RUD), trade return, disposal
• Quality Defect / Quarantine - verify quarantined product due to quality issues
• To liaise with client on the QA verification outcome and advise Logistics team on the product’s disposition accordingly

Redressing, Repackaging or Relabeling (Controlled Drugs) 20%

• Approve or reject of starting materials, packaging materials and intermediates, bulk and finished products
• Evaluate batch records
• Approve specification, sampling instructions, test methods and other quality procedures

Product Quality Complaint Management 10%     

• To manage Product Quality Complaints
• To ensure PQC monthly reconciliation report is provided to specific clients timely.

Assistance in other QA-Related tasks 10%

• Back up for QA team member
• Assist in tasks assigned by management when required.

Functional Skills and Knowledge

• Knowledge in ISO 9001/13485 standards
• Knowledge in GxP requirements (x – storage, manufacturing, distribution)
• Strong data analysis skills, management and reporting skills
• Problem-solving skills
• Demonstrated use and understanding of Quality Management System (QMS)
• Team player
• Self-motivated

Education and Experience

• Bachelor's degree in Quality or Science
• Minimum of 3 years of working experience in quality assurance fields or equivalent fields

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