Sr Executive - Production QMS

Sun Pharmaceutical Industries, Inc.; Dadra and Nagar Haveli; Sur place; INR 1 500 000 - 2 100 000; Plein temps

Résumé du poste

Sun Pharmaceutical Industries Ltd in India seeks an experienced professional to ensure QMS compliance in the Production department. You will implement and maintain documentation practices, manage deviations, and drive CAPAs to uphold product quality.

Responsibilities include preparing, reviewing, and maintaining SOPs and BMRs; ensuring timely closure of deviations and change controls; coordinating with QA for line clearance and audits; and supporting data integrity and electronic documentation

Qualifications

• 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.

Responsabilités

• 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.
• Conduct training for production staff on cGMP, SOPs, and QMS requirements.

Connaissances

cGMP

USFDA guidelines

OSD manufacturing

Documentation

Audits

Formation

B.Pharm / M.Pharm in Pharmaceutical Sciences

Description du poste

Company: Sun Pharmaceutical Industries Ltd

ob 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.
• 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.
• Participate in root cause analysis and process improvement initiatives.
• Support implementation of data integrity practices and electronic documentation systems.
• Strong knowledge ofcGMP,USFDA guidelines, and regulatory compliance.
• Experience inOSD manufacturing processes(granulation, compression, coating, packing).
• Good documentation and analytical skills.
• Ability to handle audits and regulatory inspections.

Qualification & Experience:

• B.Pharm / M.Pharmin Pharmaceutical Sciences.
• 6–10 yearsof experience in Production/QMS in a regulated OSD manufacturing environment.
• Exposure toUSFDA auditsand other international regulatory inspections preferred.