Quality Associate

About the role

The Quality Associate ensures the distribution center’s Quality System operates in full compliance with drug, medical device, and local regulations. You will support continuous improvement, conduct inspections, and act as a liaison during internal and external audits.

Key responsibilities

• Train staff on job functions and GMP requirements.
• Write, revise, and approve Standard Operating Procedures and work instructions.
• Conduct regular facility inspections, summarize findings, and report results.
• Coordinate corrective and preventive actions, and assist with regulatory audits.
• Communicate with clients and TFDA officials during external audits.
• Monitor departmental processes for regulatory compliance and operational effectiveness.
• Investigate discrepancies, advise stakeholders, and develop proactive strategies.
• Approve NCR reports and change control requests, ensuring follow‑up.
• Maintain, support, and continuously improve Quality Systems, including RP designation duties.

Required profile

• Bachelor’s degree in a science‑related field (or internationally comparable degree).
• Experience in pharmaceutical, medical device, healthcare, or food industries preferred.
• Background in Quality Assurance preferred.
• Ability to work in a regulated environment and handle audit interactions.

Required skills

• GMP knowledge and compliance.
• Standard Operating Procedure development.
• Regulatory documentation and audit liaison.