Validation Specialist - Katalyst Healthcares & Life Sciences

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.

• Analyze 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.

• Ability 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)