QA - QMS - Senior Officer

PeopleStrong; Daman; On-site; INR 500,000 - 800,000; Full time

Job summary

PeopleStrong is seeking a detail-oriented professional in Daman to manage and process Change Control records, monitor CAPAs, and maintain QMS metrics. The role involves coordinating with cross-functional teams to support quality system activities and preparing documentation for audits.

Ideal candidates must ensure compliance with quality management standards and assist in risk assessment preparations while managing comprehensive documentation.

Responsibilities

• Review and process Change Control records for completeness.
• Monitor and track open Change Controls and CAPAs.
• Prepare and maintain QMS metrics and status reports.

Job description

• Review and process Change Control records for completeness, impact assessment, and compliance with applicable procedures.
• Review CAPA (Corrective and Preventive Action) records, action plans, and effectiveness checks.
• Monitor and track open Change Controls, CAPAs, Deviations, and other QMS actions to ensure timely closure.
• Prepare and maintain QMS metrics, status reports, and action trackers.
• Review destruction reports and verify compliance with approved procedures and documentation requirements.
• Coordinate with cross-functional departments for closure of quality system activities.
• Support internal and external audits by providing required QMS documentation and records.
• Ensure proper documentation, archival, and retrieval of quality records.
• Assist in preparation of management review inputs and quality trend reports.
• Prepare and review the elemental risk assessment report.