Information Security Analyst

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Job Summary

• 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: