CSV Validation Lead
2 weeks ago
Position: CSV Validation Lead
Location: Hybrid Role
Key Responsibilities:
- Oversee the validation of systems utilized in Research & Development, Clinical, and Product Lifecycle Management.
- Manage data migration validation projects effectively.
- Possess over 8 years of experience in the Pharmaceutical sector, particularly with System Development Lifecycle.
Qualifications:
- Experience in FDA and global regulatory environments, with a solid grasp of GxP standards and risk-based validation in clinical settings.
- Familiarity with FDA guidelines and industry standards such as GAMP.
- Proficient in drafting and executing documentation for validation deliverables, including requirements, compliance plans, test protocols, and validation reports.
- Experience in reviewing system tests, user acceptance test scripts, traceability matrices, and design specifications.
Skills:
- Strong verbal and written communication abilities.
- Capable of functioning as a team player, leading teams, or executing tasks independently.
- Adept at collaborating with remote teams and managing multiple projects simultaneously.
- Ability to provide validation guidance, conduct timely reviews, and escalate issues to Technology Quality Management.
Additional Responsibilities:
- Architect, design, and develop solutions through team collaboration.
- Act as a Subject Matter Expert (SME).
- Ensure continuous knowledge enhancement and adapt to new technologies to meet quality standards and client requirements.
- Train and develop team members to maintain a skilled workforce in relevant technologies.
- Gather specifications and deliver tailored solutions based on domain or technology understanding.
- Review project deliverables for quality assurance.
- Recommend and implement client value creation initiatives, adhering to industry best practices.
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