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 setting

📌 QMS Engineer For Pharma Company (Amreli)
🏢 Pramukh Staffing
📍 Amreli