Executive Quality Assurance – Controlled Drugs

About the role

The Executive Quality Assurance professional will lead Quality Operations for Controlled Drug processes, ensuring all warehousing activities meet SOP, client and regulatory requirements. This role is responsible for inspections, verifications, and managing quality defects throughout inbound, storage, and outbound stages.

Key responsibilities

• Maintain and update the Change Control Masterlist, ensuring timely execution and reporting.
• Perform QA verification for inbound, storage, and outbound processes, including redressing, receiving, bin integrity, product segregation, labeling, and traceability.
• Validate quarantined products, liaise with clients on verification outcomes, and advise logistics on disposition.
• Approve or reject starting materials, packaging, intermediates, bulk and finished products; evaluate batch records and specifications.
• Manage Product Quality Complaints, produce monthly reconciliation reports for clients.
• Provide backup support for the QA team and assist with ad‑hoc tasks as required.

Required profile

• Bachelor's degree in Quality, Science or a related field.
• Minimum of 3 years experience in quality assurance or equivalent roles.
• Strong data analysis, reporting and problem‑solving abilities.
• Team player with self‑motivation and the ability to work independently.

Required skills

• Knowledge of ISO 9001 and ISO 13485 standards.
• Understanding of GxP requirements for storage, manufacturing and distribution.
• Experience with Quality Management Systems (QMS) and change control processes.