The QMS Executive is responsible for maintaining and improving the Quality Management System in compliance with applicable regulatory requirements, GMP guidelines, company procedures, and quality standards. The role involves handling deviations, CAPA, change controls, audits, documentation management, risk assessments, and ensuring overall compliance within the organization.
Roles & Responsibilities:
- Maintain and monitor the Quality Management System (QMS) as per current GMP requirements.
- Handling of:
- Deviations
- Incidents
- Change Controls
- CAPA
- OOS/OOT investigations
- Market complaints
- Review investigation reports and ensure timely closure of QMS records.
- Coordinate and participate in internal audits, self-inspections, and regulatory audits.
- Ensure compliance with data integrity and documentation practices.
- Conduct risk assessments using tools such as FMEA and risk matrices.
- B.Pharm / M.Pharm equivalent qualification in Pharmacy.
- 2–6 years of experience in QA/QMS activities in pharmaceutical, API, or healthcare industries.
- Knowledge of cGMP, WHO, EU, USFDA, and regulatory requirements.
- Good documentation and investigation writing skills.
- Good communication and coordination abilities.
- Ability to handle multiple tasks and meet timelines.
Preferred Knowledge:
- Data Integrity requirements
- Risk Assessment tools (FMEA)
- Regulatory audit handling
Key Performance Indicators (KPI):
- Timely closure of deviations, CAPA, and change controls
- Compliance status during audits
- Effectiveness of CAPA implementation
- QMS documentation compliance
- Training completion status
Pay: ₹200,000.00 - ₹350,000.00 per year
Benefits:
- Paid sick time
- Provident Fund
Work Location: In person
