Quality Assurance Validation Lead

2 weeks ago


California, United States Planet Pharma Full time
Job Title: Quality Assurance Validation Lead

Planet Pharma is seeking a highly skilled Quality Assurance Validation Lead to join our team. As a key member of our Quality Assurance department, you will be responsible for ensuring the Computer System Validation (CSV) and change control processes are in place and compliant with regulatory requirements.

Key Responsibilities:
  • Lead and oversee the Validation and Qualification processes for GxP Computer Systems and infrastructure to ensure adherence to 21 CFR Part 11 Compliance, GAMP-5, EU Annex 11, and other relevant regulations.
  • Recommend and review system-level configuration to fulfill security, data integrity, and regulatory requirements.
  • Design Configuration Specifications (CS) in sandboxes and implement them into Validated Systems.
  • Write, review, and approve CSV assessment documents, including GxP Computer System Risk Assessments, Part 11 Annex 11 Compliance Assessments, and GxP Computer System Data Integrity Assessments.
  • Lead installation and testing activities, including writing and overseeing Installation Qualification (IQ) Protocol and scripts, Operational Qualification (OQ) Protocol and scripts, Performance Qualification (PQ/UAT) Protocol and scripts, and Requirements Traceability Matrices (RTM).
  • Author and approve Validation Plans and Validation Summary Reports.
  • Document, evaluate, manage, and log GxP Computer System Change Control Requests (CCRs).
  • Maintain an inventory of GxP Computer Systems, assess Validation status, and prioritize actions based on risk.
  • Retire and archive IT GxP Computer Systems, including retirement/migration planning and writing retirement summary reports.
  • Provide input into IT procedures, Work Instructions (WIs), Guidance Manuals (GMs), and training materials for the development, maintenance, and use of GxP Computer Systems.
  • Evaluate potential new Computer Systems or software for GxP impact and provide risk-based Validation guidance.
  • Review incidents and changes to Computer Systems for GxP impact, identifying and executing necessary Validation or Qualification requirements.
  • Conduct and perform periodic reviews of GxP Computer Systems and user access to ensure ongoing compliance with regulatory standards and readiness for audits.
  • Perform and/or assist with Qualification Audits of GxP IT System Service Providers to ensure that these organizations are operating in a compliant manner and maintaining the required quality standards.
  • Maintain the Master Validation Plan for company computerized systems.
Requirements:
  • A minimum of two years of experience as a validation lead with direct experience in Validation in a clinical contract research organization, pharmaceutical, biotechnology, or regulated healthcare industry.
  • Strong understanding of regulations and guidance related to Computer System Validation principles and Quality Management Systems (21 CFR Part 11, GAMP-5, EU Annex 11, and other relevant regulations).
  • Bachelor's degree or equivalent experience in computer science, information technology, or a related field.
Knowledge and Skills:
  • High degree of proficiency in Microsoft Office Suite and Smartsheet.
  • Detail-oriented with a strong analytical mindset and problem-solving capabilities.
  • Strong analytical, interpersonal, writing, and problem-solving skills.
  • Self-motivated individual with a highly entrepreneurial style coupled with self-confidence and a positive attitude.
  • Excellent project management skills, with the ability to lead cross-functional teams and manage multiple projects simultaneously.
  • Well-developed problem-solving skills combined with excellent interpersonal skills with the ability to work in a positive and collaborative fashion.


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