Executive Quality Assurance

About the role

The Executive, Quality Assurance leads quality operations for Controlled Drug processes at DKSH, ensuring compliance across the entire warehousing lifecycle. This role safeguards product integrity, regulatory adherence, and client confidence through rigorous quality oversight, change control, and complaint resolution.

Key responsibilities

• Lead QA inspections, controls and verifications across all warehousing activities to ensure compliance with SOPs, work instructions, client requirements and regulatory standards.
• Manage Change Control, maintain the master list and ensure timely reporting.
• Conduct QA verification for inbound, storage, segregation, labeling, traceability and outbound activities including delivery, RUD, trade returns and disposal.
• Verify and manage quarantined products, liaise with clients on disposition guidance.
• Approve or reject starting, packaging, intermediate, bulk and finished materials involved in Controlled Drug redressing, repackaging and relabeling.
• Evaluate batch records, specifications, sampling instructions, test methods and quality procedures.
• Manage end‑to‑end Product Quality Complaints and provide monthly reconciliation reports.
• Perform self‑inspections, pre‑audits and follow‑up on observations.
• Provide backup support to the QA Manager and assist with administrative coordination as required.

Required profile

• Bachelor’s degree in Quality, Science or a related discipline.
• 1‑3 years of experience in quality assurance or equivalent; fresh graduates with relevant internships are welcome.
• Knowledge of ISO 9001 and ISO 13485 standards (advantageous).
• Familiarity with Good Practice (GxP) requirements across storage, manufacturing and distribution.
• Strong data analysis, reporting and quality management abilities.
• Effective problem‑solving skills with attention to detail.
• Demonstrated use of Quality Management Systems (QMS).
• Collaborative, self‑motivated team player willing to work full onsite.

Required skills

• ISO 9001
• ISO 13485
• GxP
• Quality Management Systems (QMS)
• Data analysis and reporting