Sr. Infrastructure Qualification

1 week ago

Newark, California, United States Adept Source Full time

Title:
Senior IT Infrastructure Qualification / CSV Consultant

Company:
Confidential

Type of Role:
Contract for 6+ Months

Location:
Newark, CA (Hybrid - 3 days onsite/week)

Description:
Our client is in search of a Senior IT Infrastructure Qualification consultant. This individual will be an integral part of the IT Research and Development Department, responsible for overseeing and executing IT Infrastructure Qualification projects in alignment with regulatory standards.

  • Provide independent technical leadership for IT Infrastructure Qualification and CSV endeavors.
  • Ensure adherence to quality and compliance standards by employing critical thinking in validation and qualification tasks.
  • Plan, review, and approve qualification packages for IT Infrastructure and GxP systems.
  • Engage with IT stakeholders to enhance existing procedures and policies for compliance.
  • Conduct gap analyses and remediation efforts to ensure compliance with regulations.
  • Collaborate in decision-making processes for system qualification.
  • Maintain communication with stakeholders to address IT Infrastructure needs.
  • Coordinate with approved vendors for successful system implementations.
  • Perform system assessments for upgrades on GxP systems.
  • Support system validation risk assessments and assist IT staff with business process deliverables for computerized systems.
  • Conduct System Periodic Reviews to ensure system validation.
  • Participate in regulatory inspections, audits, and corrective action implementations in CSV.

Requirements:
  • At least 7 years of experience in the pharmaceutical industry with GMP exposure.
  • Understanding of Validation Life Cycle approach and computer system validation requirements.
  • Knowledge of infrastructure qualification within FDA regulated environments.
  • Familiarity with industry standards and best practices for computer validation.
  • Experience in project management, SDLC phases, and IT Infrastructure systems.
  • Proficient in EDMS, VLMS, LMS, Active Directory, Backups, VMware, and Monitoring.
  • Excellent written and oral communication skills.
  • Strong time management and interpersonal abilities.
  • Effective team player with analytical problem-solving skills.

Preferred:
Relevant validation experience with Quality Systems, Manufacturing Systems, or Laboratory systems is advantageous in the pharmaceutical industry.

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