Lead GxP QA & Validation Specialist

LanceSoft Inc; Rockaway (NJ); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading consultancy firm is seeking a Lead Quality Assurance resource to provide quality support for global computer validation projects in ERP such as SAP. The ideal candidate will have a Bachelor's degree in Engineering or Sciences and 5-8 years of experience in the life sciences industry focusing on Quality Assurance. Responsibilities include reviewing validation strategies, ensuring compliance, and participating in audits. Candidates should possess strong interpersonal and organizational skills, along with knowledge of GxP systems.

Qualifications

• Minimum of 5-8 years experience in the life sciences industry focusing on Quality Assurance.
• In-depth knowledge of US FDA regulations, ISO standards, and ICH guidelines.
• Extensive experience in risk-based approaches for computer systems validation.

Responsibilities

• Review and provide input to validation and test strategies.
• Verify documentation compliance with procedures and regulations.
• Participate in audits and change management processes.

Skills

Experience with GxP Enterprise Computerized Systems

Knowledge in SAP

Microsoft Office experience

Good organization skills

Strong interpersonal skills

Education

Bachelor's Degree in Engineering or Sciences

Tools

Microsoft SharePoint

Job description

A leading consultancy firm is seeking a Lead Quality Assurance resource to provide quality support for global computer validation projects in ERP such as SAP. The ideal candidate will have a Bachelor's degree in Engineering or Sciences and 5-8 years of experience in the life sciences industry focusing on Quality Assurance. Responsibilities include reviewing validation strategies, ensuring compliance, and participating in audits. Candidates should possess strong interpersonal and organizational skills, along with knowledge of GxP systems.