Production Executive (QMS)

Milan Laboratories; Dahej; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Milan Laboratories in Dahej, India, is seeking a QA/QMS senior professional to manage production QMS activities, change controls and deviations. You will oversee CAPA workflows, root-cause analyses, and regulatory compliance, coordinating with QA, QC, engineering and validation teams to drive robust quality systems.

The role requires hands-on experience with GMP practices, document control, risk assessment, and collaboration across multiple departments to ensure timely closure of quality events

Qualifications

• Experience with QMS and GMP practices.
• Ability to perform CAPA, deviation investigations, and audits.
• Strong coordination and cross-functional collaboration skills.

Responsibilities

• Manage and coordinate QMS activities related to Production operations.
• Initiate, review, assess, and monitor Change Controls related to production processes, equipment, facilities, documents, and systems.
• Manage Deviation investigations, including root cause identification, impact assessment, investigation, and closure.
• Initiate and monitor CAPA based on deviations, incidents, audit observations, complaints, and other quality events.
• Ensure effective Root Cause Analysis (RCA) using tools like 5-Why or Fishbone.
• Coordinate and review qualification/validation activities for equipment, facility, process, cleaning, and utilities.
• Ensure qualification documents, protocols, reports, and QMS records are completed accurately and on time.
• Review and ensure SOPs, BMR/BPR, protocols, reports, and production-related documents are compliant.
• Monitor timely completion and effectiveness checks of CAPA and Change Controls.
• Participate in internal audits, regulatory inspections, customer audits, and QMS reviews.
• Ensure timely closing of audit observations and compliance actions.
• Coordinate with QA, QC, Engineering, Validation, Warehouse and other cross-functional Departments.
• Identify potential quality risks and implement risk assessment and mitigation measures.
• Adhere to GMP, data integrity, SOPs and applicable regulatory requirements.
• Prepare and review QMS-related reports, trackers, and management review data.
• Provide training to Production personnel on QMS procedures, deviations, CAPA, change control, and compliance.
• Ensure proper documentation, traceability and timely closure of all QMS activities.
• Drive continuous improvement within Production and QMS processes.

Skills

QMS knowledge

GMP awareness

Root Cause Analysis

Change control experience

Job description

Role & responsibilities

• Manage and coordinate QMS activities related to Production operations.
• Initiate, review, assess, and monitor Change Controls related to production processes, equipment, facilities, documents, and systems.
• Manage Deviation investigations, including identification of root cause, impact assessment, investigation, and timely closure.
• Initiate and monitor CAPA (Corrective and Preventive Action) based on deviations, incidents, audit observations, complaints, and other quality events.
• Ensure effective Root Cause Analysis (RCA) using appropriate investigation tools such as 5-Why, Fishbone, etc.
• Coordinate and review equipment, facility, process, cleaning, and utility qualification/validation activities as applicable.
• Ensure qualification documents, protocols, reports, and related QMS records are completed accurately and within timelines.
• Review and ensure compliance of SOPs, BMR/BPR, protocols, reports, and other production-related documents.
• Monitor the timely completion and effectiveness checks of CAPA and Change Controls.
• Participate in internal audits, regulatory inspections, customer audits, and QMS reviews.
• Ensure timely implementation and closure of audit observations and compliance actions.
• Coordinate with QA, QC, Engineering, Validation, Warehouse, and other cross-functional departments for QMS activities.
• Identify potential quality risks and support implementation of appropriate risk assessment and mitigation measures.
• Ensure adherence to GMP, data integrity, SOPs, and applicable regulatory requirements.
• Prepare and review QMS-related reports, trackers, and management review data.
• Provide training and guidance to Production personnel on QMS procedures, deviations, CAPA, change control, and compliance requirements.
• Ensure proper documentation, traceability, and timely closure of all assigned QMS activities.
• Drive continuous improvement initiatives within Production and QMS processes.

Preferred candidate profile

• 1. Immediate Joiner
• 2. Pharmaceutical experience only