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Validation Specialist

2 months ago

Raritan, New Jersey, United States Tricon Solutions Full time

Job Summary:

Tricon Solutions is seeking a highly experienced Validation Specialist to join our team. As a key member of our organization, you will be responsible for ensuring the quality and integrity of our computer systems and processes.

Key Responsibilities:

  • Lead Validation Efforts: Guide project teams in the development and implementation of validation plans, protocols, and reports.
  • Regulatory Compliance: Ensure adherence to FDA guidelines and industry standards, including GAMP and 21 CFR Part 11.
  • Business Analysis: Collaborate with stakeholders to understand business requirements and develop documentation for software development.
  • Project Management: Manage multiple GxP projects, prioritize tasks, and facilitate interaction between project teams and business stakeholders.
  • Training and Development: Provide guidance and training to project teams on policies, procedures, and tools.
  • Technical Expertise: Possess strong knowledge of project management tools, such as JIRA, and be able to manage project priorities based on identified risks.

Requirements:

  • 10 years of experience in Computer System Validation, Quality Management, or Business Analysis in a GxP application area.
  • Working experience in Clinical Development, Supply Chain, Drug Discovery, MES, QMS, LIMS, Data Integrity Platforms, or related domains.
  • Strong communication skills to interact with business stakeholders and interpret business rules and requirements.
  • Expertise in documenting and guiding various SDLC deliverables, including requirements specification, user stories, criticality assessment, test plans, design documentation, validation plans, risk assessments, and validation strategies.

What We Offer:

Tricon Solutions is a dynamic and growing organization that values its employees and provides opportunities for professional growth and development.