Validation Engineer

Updated: June 02, 2024 05:56 AM GMT

ZXT RUIFENG TRADING SDN. BHD.

Gurun, Kedah

Description

Validation Planning and Strategy:

Develop validation plans, protocols, and reports (IQ/OQ/PQ).
Create and maintain validation master plans.
Define validation strategies and establish acceptance criteria.

Technical Proficiency:

Strong understanding of validation principles and methodologies (e.g., IQ/OQ/PQ).
Proficiency in validation software and tools.
Knowledge of statistical analysis and data interpretation techniques.

Regulatory Knowledge:

In-depth knowledge of regulatory requirements and industry standards (e.g., FDA, EMA, GMP, ISO 13485).
Experience with risk management and regulatory compliance documentation.

Communication Skills:

Effective written and verbal communication skills.
Ability to convey technical information to non-technical stakeholders.
Experience in preparing clear and concise technical reports and documentation.

Continuous Improvement Mindset:

Proactive approach to identifying and implementing improvement opportunities.
Familiarity with... More Detail