Key Responsibilities:

- Deviation Management & Investigation

- Identify and document deviations in the production process

- Conduct thorough investigations and implement corrective actions

- Root Cause & Impact Analysis

- Perform detailed root cause analysis and assess the impact on product quality and safety

- Market Complaint Handling

- Lead investigations and resolve market complaints in coordination with QA/QC

- Prepare detailed reports and response documents

- CAPA (Corrective & Preventive Actions)

- Track and ensure timely implementation of CAPAs

- Monitor effectiveness and support closure

- Change Control & Risk Assessment

- Handle change control processes for production operations

- Perform risk assessments for proposed changes

- Documentation & Compliance

- Prepare and review Batch Manufacturing Records (BMR), protocols, and SOPs

- Ensure documentation adheres to cGMP and regulatory standards

- Audit & Internal Compliance

- Support internal and external audits (Regulatory, Client, ISO, etc.)

- Address audit observations and implement improvements

- Maintain readiness for inspections at all times

Interested candidates can also mail their resume on [email protected]

📌 Officer/Senior Officer - Production QMS (Indore)
🏢 Gufic Biosciences
📍 Indore