Location : Remote

Experience : 5+ Years in Computer System Validation (CSV) and GxP regulated environments

About The Role

We are seeking experienced and highly motivated freelance CSV & GxP Consultants to join our team. As a key member, you will provide expert guidance and support in managing and validating IT systems within a GxP regulated environment. You will be responsible for ensuring compliance with relevant regulations (e.g., FDA 21 CFR Part 11, EU Annex 11) and industry best practices. This role demands a strong understanding of IT infrastructure, change management, and incident/problem resolution, coupled with meticulous documentation and validation skills.

Responsibilities

• Provide day-to-day management and support of GxP regulated IT systems.
• Ensure systems operate in a compliant and efficient manner.
• Maintain system integrity and data security.
• Develop, execute, and review validation documentation (e.g., Validation Plans, User Requirements Specifications, Functional Requirements Specifications, Design Specifications, Test Protocols, Validation Summary Reports).
• Perform risk assessments and ensure appropriate validation strategies are implemented.
• Maintain a thorough understanding of current regulatory requirements and industry best practices related to CSV.
• Provide expertise in IT infrastructure components relevant to GxP systems.
• Ensure infrastructure compliance with regulatory requirements.
• Work with infrastructure teams to maintain systems.
• Manage changes to GxP systems through a controlled change management process.
• Ensure all changes are properly documented and validated.
• Oversee the release management process to ensure smooth and compliant system updates.
• Respond to and resolve incidents and problems related to GxP systems.
• Conduct root cause analysis and implement corrective and preventive actions (CAPA).
• Maintain accurate records of incidents and problem resolutions.
• Create and maintain comprehensive documentation, including SOPs, work instructions, and validation reports.
• Ensure all documentation is accurate, complete, and compliant with regulatory requirements.
  
  

Compliance

• Ensure all work complies with applicable GxP regulations and internal policies.
  
  

Mandatory Skills

• Minimum 5 years of experience in CSV within a GxP regulated environment (e.g., pharmaceutical, biotechnology, medical device).
• Strong working knowledge of Computer System Validation principles and practices.
• Extensive experience in GxP system management.
• Proven experience with IT infrastructure management.
• Demonstrated expertise in change and release management processes.
• Proficiency in incident and problem management.
• Excellent documentation and communication skills.
• Understanding of 21 CFR Part 11 and EU Annex 11.
  
  

Preferred Skills

• Experience with specific GxP systems (e.g., LIMS, ERP, QMS).
• Knowledge of ITIL framework.
• Experience working with cloud based GxP systems.
• Experience with automated testing tools.
  
  

Personal Attributes

• Highly organized and detail-oriented.
• Strong analytical and problem-solving skills.
  
  

- Ability to work independently and as part of a team. -

• Excellent communication and interpersonal skills.
  
  

- Ability to manage multiple projects and priorities. -

• Self motivated.
  
  

(ref:hirist.tech)