Senior Validation QA

Responsibilities

• Maintaining effective qualification and validation systems, ensuring compliance with the latest regulatory expectations.
• Review and approve qualification and validation-related procedures.
• Perform commissioning and qualification activities at the WuXi XDC Singapore site.
• Review and approve validation-related documents.
• Ensure that the company’s CQV policies and procedures are strictly followed during initial qualification and requalification processes.
• Participate in the investigation of issues arising during qualification and validation activities, assess their potential impact on validation status, and review and approve the investigation reports.
• Participate in internal and external audits, collaborating with the validation team to address observations and develop CAPA plans.
• Perform other tasks as assigned by leadership.

Qualifications

• Bachelor's degree or higher in Biologics, Pharmacy, Pharmaceutical Engineering, Bioengineering, or other relevant fields.
• Proficient in English listening, speaking, reading, and writing.
• Skilled in Microsoft Word, Excel, PowerPoint, etc.
• Strong problem-solving skills.
• Logical thinker.
• Strong learning ability.
• Skilled in cross-functional communication and collaboration.