QC Validation Lead

Full-time IT & Technology

We are currently seeking a QC Validation Lead to join our QC Laboratory team. This position reports directly to the QC Manager and is based in Ampang, Selangor.

Key Responsibilities

• Lead the development, execution, and documentation of Analytical Method Validation (AMV) protocols and reports for raw materials, in-process samples, finished products, and stability studies.
• Conduct cleaning validation analytical testing, periodic validation reviews, and laboratory equipment qualification activities.
• Ensure implementation, maintenance and compliance of Computerized System Validation (CSV) requirements in the QC laboratory environment.
• Support analytical method transfer activities, and perform pharmacopoeial updates, gap assessments and impact evaluations to keep testing methods aligned with current regulatory and compendial standards.
• Drive continuous improvement initiatives related to validation, laboratory compliance, data in...