Job Title: Validation Lead
Job Description:
We are seeking a skilled and detail-oriented Validation Lead to join our team. The ideal candidate will have a strong background in validation processes, particularly in regulated environments. The Validation Lead will play a critical role in ensuring the quality and compliance of deliverables by working closely with cross-functional teams and our clients.
Key Responsibilities:
Thoroughly understand user and functional requirements documents
Prepare comprehensive test plans in alignment with project objectives
Assist the Validation Manager in task assignment and team coordination
Author and review OQ (Operational Qualification) and PQ (Performance Qualification) test scripts, especially for complex requirements
Collaborate with customers to clarify requirements and ensure expectations are met
Review and maintain Requirement Traceability Matrices (RTM)
Participate in customer meetings (daily and weekly status updates)
Coordinate with customers for the pre-approval and post-approval of validation protocols
Provide daily and weekly project status reports to the customer
Facilitate the closure of defects in collaboration with the project team and customer
Execute test cases formally when necessary
Provide guidance and clarification to team members on project tasks and requirements
Ensure timely and high-quality completion of all project deliverables
Promote and support the adoption of best practices for improving quality
Desirable Skills and Experience:
Proven experience in computer system validation (CSV) or equipment validation in a regulated industry (e.g., pharmaceutical, biotech, medical devices)
Strong understanding of OQ/PQ protocol development and execution
Familiarity with GxP compliance, FDA regulations (21 CFR Part 11), and industry standards (e.g., GAMP 5)
Experience with RTM, defect tracking tools, and test management systems
Excellent written and verbal communication skills
Ability to coordinate with cross-functional teams and work directly with clients
Strong organizational and analytical skills
Proactive attitude and attention to detail
Experience mentoring or leading a validation team is a plus
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Japan | Saitama |Tokyo :
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