Validation Specialist

2 weeks ago

Raleigh, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • The Validation Specialist will be responsible for the validation of computer systems and processes, ensuring compliance with regulatory requirements.
  • Validation Processes this role will involve significant interaction with data analytics and RIM to support and enhance our compliance and validation activities.
  • The ideal candidate will have a strong background in validation processes, data analytics, and regulatory information management.
  • Develop and execute validation protocols (IQ/OQ/PQ) for computer systems and software applications.
  • Conduct risk assessments and create validation master plans in accordance with regulatory guidelines.
  • Ensure all validation activities comply with GxP, FDA, EMA, and other relevant regulatory standards Data Analytics.
  • Utilize data analytics to monitor and assess system performance and compliance.
  • nalyze validation data to identify trends, anomalies, and areas for improvement.
  • Provide data-driven insights to support decision-making in validation and compliance processes.
  • Regulatory Information Management. (RIM)
  • Ensure that all validation activities align with regulatory requirements and are documented within the RIM system.
  • Maintain and manage regulatory documentation and records, ensuring accuracy and compliance.
  • Support regulatory submissions by providing validated data and documentation as required.
  • Collaboration and Communication.
  • Work closely with cross-functional teams, including IT, Quality Assurance, Regulatory Affairs, and Data Management, to ensure successful validation activities.
  • Provide training and guidance on validation processes and regulatory compliance to team members.
  • Prepare and present validation reports to stakeholders and regulatory bodies as needed.
  • Continuous Improvement:
  • Identify opportunities to enhance validation processes through data analytics and automation.
  • Stay updated with industry best practices, regulatory changes, and advancements in validation technology.
  • Lead or participate in continuous improvement initiatives related to validation and regulatory compliance.
Requirements:
  • Bachelor s degree in Computer Science, Engineering, Life Sciences, or a related field. A Master s degree is preferred.
  • Proven experience as a Validation Specialist, Validation Engineer, or similar role, with a focus on computer system validation.
  • Strong expertise in Data Analytics, with experience using tools like SQL, Python, R, or equivalent.
  • Experience with Regulatory Information Management (RIM) systems and regulatory submissions.
  • In-depth knowledge of GxP, FDA, EMA, and other relevant regulatory standards.
  • Excellent analytical, problem-solving, and communication skills.
  • bility to work independently and as part of a cross-functional team.
  • Strong organizational skills and attention to detail.
  • Experience in the pharmaceutical, biotechnology, or medical device industry.
  • Familiarity with quality management systems (QMS) and electronic document management systems. (EDMS)
  • Certification in Computer System Validation or related disciplines is a plus.
  • Skills needed Strong in Validation process, Data Analytics and Regulatory Information Management. (RIM)

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