QMS Executive Biounit

T.Stanes and Company Limited; Coimbatore District; On-site; INR 450,000 - 650,000; Full time

Job summary

Maintain and coordinate QMS documentation and compliance activities for the Bioproduction Unit, supporting consistent adherence to approved procedures and quality standards.

This role requires coordinating document preparation, review, issue, revision, retrieval, archival and ensuring timely closure of gaps, deviations, CAPA and change controls. You will also support audits, training tracking and data compilation for quality reviews.

Responsibilities

• Maintain controlled documents, SOPs, formats, registers, specifications and records as per the document-control procedure.
• Coordinate document preparation, review, approval, issue, revision, retrieval and archival.
• Track deviations, non-conformances, corrective and preventive actions (CAPA), change controls and other QMS actions through closure.
• Coordinate internal audits, external/customer audits and inspection readiness; track observations and follow-up actions.
• Monitor training records and ensure employees receive required training on relevant SOPs and procedures.
• Support investigation of quality issues and compile data for trend analysis and periodic quality reviews.
• Check documentation for completeness, traceability, legibility and timely closure; escalated gaps to the reporting manager.
• Coordinate with Production, Quality Control, Maintenance and other teams to promote QMS awareness and continual improvement.

Job description

Job Summary: Maintain and coordinate QMS documentation and compliance activities for the Bioproduction Unit, supporting consistent adherence to approved procedures and quality standards.

Key Responsibilities

• Maintain controlled documents, SOPs, formats, registers, specifications and records as per the document-control procedure.
• Coordinate document preparation, review, approval, issue, revision, retrieval and archival.
• Track deviations, non-conformances, corrective and preventive actions (CAPA), change controls and other QMS actions through closure.
• Coordinate internal audits, external/customer audits and inspection readiness; track observations and follow-up actions.
• Monitor training records and ensure employees receive required training on relevant SOPs and procedures.
• Support investigation of quality issues and compile data for trend analysis and periodic quality reviews.
• Check documentation for completeness, traceability, legibility and timely closure; escalated gaps to the reporting manager.
• Coordinate with Production, Quality Control, Maintenance and other teams to promote QMS awareness and continual improvement.