Senior Executive QMS Investigator

Drlogy; India; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Drlogy is seeking an experienced Senior Executive QMS Investigator responsible for managing quality investigations and CAPA implementation within pharmaceutical contexts. The ideal candidate will ensure adherence to GMP standards while supporting quality improvement initiatives.

This role involves conducting thorough investigations, coordinating with QA and production teams, and participating in audits and compliance reviews. Strong proficiency in regulatory compliance and excellent documentation skills are critical.

Qualifications

• Experience as a Senior Executive QMS Investigator in pharmaceutical manufacturing.
• Strong proficiency in quality investigations and deviation handling.
• Expertise in regulatory compliance and audit coordination.

Responsibilities

• Conduct quality investigations efficiently.
• Perform root cause analysis for quality-related incidents.
• Implement CAPA and monitor corrective actions.
• Ensure compliance with GMP standards.

Skills

Quality investigations

Deviation handling

CAPA implementation

Regulatory compliance

Root cause analysis

Audit coordination

Quality systems management

GMP standards

Job description

Overview

Experienced Senior Executive QMS Investigator responsible for managing quality investigations, deviation handling, CAPA implementation, and compliance monitoring within pharmaceutical manufacturing environments. Skilled in root cause analysis, audit coordination, quality systems management, and regulatory compliance. Adept at ensuring operational excellence and adherence to GMP standards while supporting continuous quality improvement initiatives.

Responsibilities

• Conduct quality investigations and deviation handling activities efficiently.
• Perform root cause analysis for quality-related incidents and deviations.
• Implement CAPA and monitor effectiveness of corrective actions.
• Ensure compliance with GMP and pharmaceutical quality standards.
• Coordinate with QA, QC, and production teams for investigation support.
• Review investigation reports and quality documentation accurately.
• Participate in internal audits and regulatory inspection activities.
• Monitor implementation of quality systems and compliance procedures.
• Maintain records related to deviations, CAPA, and change controls.
• Support risk assessment and quality improvement initiatives.
• Conduct training on QMS and investigation procedures for staff.
• Ensure timely closure of quality investigations and observations.
• Prepare compliance reports and quality performance summaries.
• Support document control and quality management activities.
• Contribute to continuous improvement and operational excellence programs.

Qualifications

• Experience as a Senior Executive QMS Investigator in pharmaceutical manufacturing or related regulated environment.
• Strong proficiency in quality investigations, deviation handling, CAPA design/effects, and regulatory compliance.
• Expertise in root cause analysis, audit coordination, and quality systems management under GMP.
• Ability to coordinate with QA, QC, and production teams; strong documentation skills.
• Experience with change controls and risk assessment processes; training delivery in QMS procedures.