Sun Pharmaceutical Industries, Inc.
Senior Executive - Production QMS
Sun Pharmaceutical Industries, Inc., Indiana, Pennsylvania, us, 15705
Title: Senior Executive - Production QMS
Location: Dadra 1 - Operations Block A
Company: Sun Pharmaceutical Industries Ltd
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.
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 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.
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Company: Sun Pharmaceutical Industries Ltd
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.
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 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.
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