QMS Engineer For Pharma Company

Job Description:

Position Overview

We are looking for a QMS Engineer (Executive) with experience in pharmaceutical formulation (OSD) to manage and maintain the Quality Management System (QMS) in compliance with regulatory requirements such as ICH, WHO-GMP, USFDA, and EU-GMP.

Key Responsibilities

1. Documentation Management

• Prepare, review, and control SOPs, STPs, formats, and policies
• Ensure proper document lifecycle management (issuance, revision, archival)
• Maintain documentation as per GDP (Good Documentation Practices)

2. QMS Activities

• Handle deviations, CAPA, change control, and incident management
• Ensure timely closure and effectiveness check of CAPA
• Support continuous improvement of QMS processes

3. Compliance & Audit

• Ensure site compliance with ICH Q10, WHO-GMP, USFDA, and EU-GMP guidelines
• Participate in internal and external audits
• Prepare audit responses and ensure compliance closure

4. Risk Management

• Perform Quality Risk Management (QRM) using tools like FMEA and HACCP
• Identify and mitigate risks in processes and systems

5. Training & Coordination

• Conduct and coordinate QMS and GMP training programs
• Work closely with Production, QC, and other departments for QMS implementation

Desired Profile / Criteria / Skills :

Qualification

• Diploma / Bachelor’s Degree in Engineering or Pharmacy / Science

Required Skills

• Strong knowledge of QMS systems in pharma (OSD)
• Hands-on experience in deviation, CAPA, change control
• Good understanding of regulatory guidelines
• Strong documentation and communication skills
• Attention to detail and problem-solving ability

Preferred Candidate Profile

• Experience in OSD (Oral Solid Dosage) manufacturing plant
• Exposure to regulatory audits (USFDA / EU / WHO)
• Ability to work in a structured and compliance-driven environment