Executive Quality Assurance

DKSH

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Job Description

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%

Functional Skills And Knowledge

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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