Job Summary
The QMS Production Executive is responsible for implementing and maintaining the Quality Management System (QMS) within the Production Department. The role ensures compliance with GMP, SOPs, regulatory requirements, and company quality standards while supporting documentation, investigations, audits, and continuous improvement activities.
Key Responsibilities
- Ensure compliance with cGMP, GDP, SOPs, and company quality policies.
- Prepare, review, and maintain production-related SOPs, BMRs, BPRs, logbooks, formats, and records.
- Manage production QMS documentation, including document control and archival.
- Initiate and track Change Controls, Deviations, CAPA, and Incident Reports.
- Coordinate risk assessments and implement corrective and preventive actions.
- Conduct periodic review of production documents for compliance and accuracy.
- Ensure timely closure of deviations, CAPAs, and change controls.
- Coordinate with QA, QC, Warehouse, Engineering, and other departments for QMS-related activities.
- Support internal, customer, and regulatory audits and ensure timely compliance with audit observations.
- Conduct GMP and SOP training for production personnel and maintain training records.
- Monitor production compliance and identify opportunities for process improvement.
- Ensure data integrity and proper documentation practices across the production department.
- Assist in qualification and validation documentation as required.
- Prepare monthly QMS reports and KPI dashboards for management review.
Qualifications
- Bachelor's degree in Pharmacy (B.Pharm), M.Pharm, B.Sc., M.Sc., or a related Life Sciences discipline.
Experience
- 2–5 years of experience in pharmaceutical manufacturing with exposure to Production QMS.
- Experience in oral solid dosage, liquid, or injectable manufacturing is preferred.
Required Skills
- Strong knowledge of cGMP, WHO-GMP, Schedule M, and regulatory requirements.
- Good understanding of Change Control, Deviation, CAPA, Risk Assessment, and Documentation practices.
- Proficiency in Microsoft Office (Excel, Word, PowerPoint).
- Excellent documentation and communication skills.
- Strong analytical and problem-solving abilities.
- Ability to work in a cross-functional team environment.
Key Performance Indicators (KPIs)
- Timely closure of Deviations, CAPAs, and Change Controls.
- Compliance with GMP and documentation standards.
- Audit readiness and audit observation closure.
- On-time SOP review and document revision.
- Training compliance of production personnel.
- Reduction in documentation errors and repeat deviations.
Working Conditions
- Manufacturing plant environment.
- May require shift support and availability during regulatory audits or inspections.
Pay: ₹18,317.90 - ₹35,040.61 per month
Work Location: In person
