Executive, Quality Assurance (Quality Compliance & Operations)

• Company bus to and from work at multiple MRT stations.
• Working location: Jalan Buroh
• Monday-Friday, 8.30am-5.30pm
• DKSH is a certified Great Place To Work!

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.
• Act as back up for Manager, Quality Assurance on areas as assigned during his/her absence.

Job Responsibilities

• Compliance of Warehousing Processes

1. 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)

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

• Change Control Management

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

• Assistance in other QA-Related tasks

1. Act as back up for QA team member.
2. Assist in tasks assigned by management when required.

Job Requirements

• 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).
• Bachelor's degree in Quality or Science-related.
• Minimum of 3 years of working experience in Quality Assurance or equivalent fields.