CSV Validation Lead

2 weeks ago


Raritan, New Jersey, United States Zodiac Solutions Full time
Job Overview

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:

  1. Architect, design, and develop solutions through team collaboration.
  2. Act as a Subject Matter Expert (SME).
  3. Ensure continuous knowledge enhancement and adapt to new technologies to meet quality standards and client requirements.
  4. Train and develop team members to maintain a skilled workforce in relevant technologies.
  5. Gather specifications and deliver tailored solutions based on domain or technology understanding.
  6. Review project deliverables for quality assurance.
  7. Recommend and implement client value creation initiatives, adhering to industry best practices.

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