QA Complaints & Regulatory Associate II

Alcon Indonesia; Batam; Vor Ort; IDR 120.000.000 - 180.000.000; Vollzeit

Zusammenfassung

Alcon Indonesia invites you to join our Quality & Regulatory Affairs team as Associate II, Complaints (Professional Path), responsible for processing, investigating, and monitoring product defect complaints and serving as the main contact for regulatory reporting.

You will collaborate with Medical Safety and Research & Development on adverse events, maintain compliant documentation under GxP, SOPs, and drive improvements in complaint handling.

Qualifikationen

• Diploma or Bachelor’s Degree in Science, Life Sciences, or Engineering (Open to recent grads).
• Experience in root cause analysis and structured problem solving.
• Familiarity with medical devices or pharmaceutical regulations is an advantage.
• Ability to communicate effectively in English, both orally and in writing.
• Strong communication and problem-solving skills to articulate project experience and provide effective responses.

Aufgaben

• Handle complex tasks and contribute to advanced projects in the Complaints discipline.
• Process, investigate, and monitor product defect complaints and regulatory reporting.
• Collaborate with Medical Safety and R&D on adverse events.
• Adhere to GxP regulations and SOPs with proper documentation.
• Support complaint activity monitoring and propose process improvements.

Kenntnisse

Root cause analysis

Structured problem solving

English communication

Problem-solving

Ausbildung

Diploma or Bachelor’s Degree in Science, Life Sciences, or Engineering

Jobbeschreibung

Alcon Indonesia invites you to join our Quality & Regulatory Affairs team as Associate II, Complaints (Professional Path), responsible for processing, investigating, and monitoring product defect complaints and serving as the main contact for regulatory reporting.

You will collaborate with Medical Safety and Research & Development on adverse events, maintain compliant documentation under GxP, SOPs, and drive improvements in complaint handling.