Quality Assurance Compliance Associate

About the role

Alcon is seeking a Quality Assurance Compliance Associate to support the implementation and maintenance of its Quality Management System at the Singapore site. You will ensure alignment with Alcon standards, customer expectations, and regulatory requirements while contributing to a culture of quality and continuous improvement.

Key responsibilities

• Support inspection readiness activities, including preparation for internal audits and regulatory inspections (Health Authorities, Notified Bodies).
• Coordinate and track responses to inspection observations to ensure timely closure.
• Review and approve change controls in line with regulatory expectations.
• Maintain compliance with GMP, ISO 13485, MDSAP, EU MDR, and local regulations such as HSA.
• Manage the site training program, monitor completion, address gaps, and keep training records inspection‑ready.
• Support data integrity initiatives and promote ALCOA+ principles.
• Compile and analyse quality metrics and contribute to Management Review reporting.
• Prepare Annual Product Quality Review (APQR) reports and support document control processes.
• Identify and drive continuous improvement opportunities within quality systems.

Required profile

• Degree in Pharmacy, Chemistry, Biotechnology, Life Sciences or a related field.
• At least 3 years of experience in Quality Assurance or Compliance within the pharmaceutical or medical device industry.
• Strong attention to detail and a compliance‑focused mindset.

Required skills

• Knowledge of GMP and ISO 13485 quality systems.
• Familiarity with regulatory frameworks such as HSA, EU MDR and MDSAP.
• Understanding of data integrity principles (ALCOA+).