Job Description

The job description is as below:

• Perform and oversee audits (facility-based, process-based, and study-based) as per OECD GLP guidelines.
• Review and verify raw data, reports, and study plans for compliance with applicable GLP standards.
• Ensure that standard operating procedures (SOPs) are current and being followed across departments.
• Monitor the conduct of pharmacology, toxicology and analytical studies to ensure regulatory compliance.
• Participate in regulatory inspections and ensure laboratory preparedness.
• Maintain audit schedules, documentation, and deviation tracking systems.
• Provide training and guidance on GLP compliance and QAU processes to laboratory personnel.
• Support in drafting Quality Assurance Statements and internal audit reports.

Skills and Competencies:

• Strong understanding of OECD GLP principles and regulatory requirements.
• Hands-on experience with auditing techniques and documentation review.
• Good communication and interpersonal skills.
• High attention to detail and analytical thinking.
• Ability to work independently and as part of a cross-functional team.

Preferred Experience:

• Prior experience in QAU department in GLP environment.
• Exposure to regulatory audits (e.g., OECD, NABL, FDA, AAALAC, etc.).
• Experience with digital data systems and QA documentation tools.

For further details call Megha on 9377677857 or you can mail your candidature on megha@postaresume.co.in

Skills Required