Job Description

Job Purpose:
To ensure compliance with cGMP, USFDA, and other regulatory requirements by implementing and maintaining Quality Management System (QMS) practices within the Production department. Responsible for documentation, deviation handling, and continuous improvement initiatives to maintain product quality and regulatory compliance.
Key Responsibilities:
QMS Compliance & Documentation

• Prepare, review, and maintain SOPs, Batch Manufacturing Records (BMR), and related production documents.
• Ensure timely closure of deviations, change controls, and CAPAs related to production activities.
• Maintain compliance with USFDA, MHRA, and other global regulatory standards.

Batch Execution & Monitoring

• Monitor batch manufacturing processes to ensure adherence to approved procedures.
• Coordinate with QA for line clearance and in-process checks.

Deviation & Investigation Handling

• Initiate and investigate production-related deviations.
• Prepare investigation reports and implement corrective and preventive actions.

Training & Compliance

• Conduct training for production staff on cGMP, SOPs, and QMS requirements.
• Ensure readiness for regulatory audits and inspections.

Continuous Improvement

• Participate in root cause analysis and process improvement initiatives.
• Support implementation of data integrity practices and electronic documentation systems.

Key Skills & Competencies:

• Strong knowledge of cGMP, USFDA guidelines, and regulatory compliance.
• Experience in OSD manufacturing processes (granulation, compression, coating, packing).
• Good documentation and analytical skills.
• Ability to handle audits and regulatory inspections.

Qualification & Experience:

• B.Pharm / M.Pharm in Pharmaceutical Sciences.
• 6-10 years of experience in Production/QMS in a regulated OSD manufacturing environment.
• Exposure to USFDA audits and other international regulatory inspections preferred.

Skills Required