Junior Auditor

Job Title: Junior Auditor - Quality Assurance (QA) Department

Job Summary:

The Junior Auditor in the QA Department assists in performing internal quality audits to ensure compliance with company policies, industry standards (e.g., ISO, GMP, FDA), and regulatory requirements. This role involves document review, data analysis, audit preparation, reporting, and follow-up on corrective and preventive actions (CAPAs).

Key Responsibilities:

• Audit Support & Execution:

• Assist in planning and conducting internal audits for various departments to verify compliance with quality standards.
• Participate in process and system audits under the guidance of senior auditors or QA managers.
• Support the audit lifecycle including scheduling, data gathering, fieldwork, reporting, and follow-up.

• Documentation & Reporting:

• Review quality documents, standard operating procedures (SOPs), and records for completeness and compliance.
• Document audit findings clearly and concisely.
• Assist in preparing audit reports and tracking corrective actions to closure.

• Regulatory Compliance:

• Help ensure compliance with applicable regulations such as ISO 9001, GMP, GLP, FDA, or other relevant standards.
• Stay updated on regulatory changes and support the QA team in implementing necessary updates.

• Data Analysis & Review:

• Collect and analyze QA data, including trends in non-conformities, CAPA effectiveness, and risk assessments.
• Assist in monitoring key quality metrics.

• Support Continuous Improvement:

• Provide input on quality improvements based on audit findings.
• Assist QA team in implementing process enhancements and best practices.

Qualifications:

• Education:

• Bachelors degree in Quality Management, Life Sciences, Engineering, Pharmacy, or a related field.

• Experience:

• 02 years of experience in quality assurance, quality control, or internal auditing (internships or co-op positions acceptable).
• Exposure to quality standards (ISO, GMP, etc.) is a plus.

• Skills:

• Strong attention to detail and organizational skills.
• Ability to work independently and as part of a team.
• Basic understanding of QA principles and auditing methodologies.
• Good written and verbal communication skills.
• Proficient in Microsoft Office (Word, Excel, PowerPoint).

Preferred Qualifications:

• Knowledge of document control systems.
• Familiarity with risk-based auditing.
• Coursework or certifications in quality management or auditing (e.g., ISO 9001, GMP).
• Experience using audit management software or tools.