QA Auditor

Navitas Life Sciences Pvt. Ltd.; Bengaluru; On-site; INR 600,000 - 1,200,000; Full time

Job summary

Navitas Life Sciences Pvt. Ltd. in Bengaluru seeks a QA Auditor to join the Corporate Services team. The role includes conducting audits of projects, systems, and vendors, assessing regulatory compliance, and reporting audit results in an unbiased manner.

Responsibilities include evaluating SOP deviations, supporting CAPA investigations, hosting customer audits, and providing QA consultancy on regulatory requirements and SOPs. The position supports QMS implementation and QA initiatives.

Qualifications

• Experience in clinical trial audits.
• Experience in site investigator audits.
• Graduate degree required.

Responsibilities

• Conduct audits of projects, systems, processes, and vendors as assigned.
• Assess compliance with regulations, guidelines, and customer requirements.
• SOPs and reporting of the audit in an unbiased manner.
• Evaluate and manage SOP deviations, quality issues and complaints by investigating root causes and developing CAPAs.
• Support for preparing for and hosting customer audits and inspections.
• Prepare SOPs and support SOP review.
• Provide QA consultancy to project teams on regulatory requirements, guidelines, and SOPs as required.
• Support effective implementation and maintenance of Quality Management System.
• Lead and support other departmental activities and QA initiatives.

Skills

Clinical trial audits

Site investigator audits

Education

Graduate

Job description

Job Description

We are currently seeking a QA Auditor to join our Corporate Services team. The role will include the following:

• Conduct audits of projects, systems, processes, and vendors, as assigned
• Assess compliance with applicable regulations, guidelines, and customer requirements,
• SOPs and reporting of the audit in an appropriate and unbiased manner
• Evaluate and effectively manage SOP deviations, quality issues and complaints by supporting with investigation of the root cause and developing adequate Corrective Actions and Preventive Actions (CAPAs)
• Support with preparing for and hosting customer audits and inspections
• Prepare SOPs and support with review of SOPs
• Provide QA consultancy to project teams on regulatory requirements, guidelines, and SOPs, as required
• Support with effective implementation and maintenance of Quality Management System
• Lead and support with other departmental activities and QA initiatives

Desirable Skills and Experience

• Experienced in Clinical trial audits
• Experienced in Site investigator audits

Bangalore, India

Graduate