Information Security Analyst

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Job Description:

Job Summary

The Information Security Analyst is responsible for identifying, documenting, and investigating deviations as part of the IT Quality Assurance process. This role works closely with both Quality Assurance and IT teams to determine root causes, and to develop and document corrective and preventive action plans. The analyst ensures that deviations are addressed promptly and that measures are implemented to prevent recurrence.

Job Description:

• Draft and document deviations, ensuring clarity, accuracy, and compliance with internal and regulatory standards.
• Work closely with operations, quality assurance, and other relevant teams to gather information related to deviations.
• Classify and prioritize deviations based on risk assessment and impact.
• Participate in deviation investigations, conducting interviews, reviewing batch records, and analyzing processes to identify root causes.
• Utilize root cause analysis tools (e.g., 5 Whys, Fishbone Diagrams) to support investigations.
• Develop and document effective Corrective Action Plans (CAPAs) and Preventive Action Plans based on investigation findings.
• Ensure timely implementation and verification of CAPAs to prevent recurrence.
• Ensure all deviation reports are complete, concise, and submitted within defined timelines.
• Maintain accurate and organized records for audits and inspections.
• Generate and analyze deviation trend reports to identify recurring issues or trends.
• Stay updated on relevant regulatory requirements (e.g., FDA, EMA, ISO) and industry best practices.
• Propose process improvements to reduce deviations and enhance product quality.
• Provide cross-training and guidance to staff on deviation reporting procedures.
• Flexible to work in different time zones
  
  

Qualifications:

• Bachelor’s degree in a relevant field (e.g., Information Technology, Computer Science, Data Science, or related discipline).
• Overall, 5 years of experience with 2+ years of experience in quality assurance, manufacturing, or compliance within a GMP-regulated industry.
• Hands-on experience with deviation investigations and root cause analysis.
• Strong technical writing and documentation skills with attention to detail.
• Excellent communication and interpersonal skills for cross-departmental collaboration.
• Proficiency in using electronic quality management systems (eQMS) and deviation tracking tools.
• Analytical thinking with problem-solving abilities.
• Thorough understanding of GMP regulations and quality management systems.
• Familiarity with manufacturing processes, batch record reviews, and IT investigations.
  
  

Employee Type:

Permanent

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