Sr Executive – Production QMS

Qvents.In; Dadra and Nagar Haveli; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Sun Pharmaceutical Industries Ltd. in Dadra and Nagar Haveli seeks a Senior Executive to ensure QMS compliance within Production. The role focuses on documentation, deviation handling, and continuous improvement to meet cGMP and USFDA standards.

You will prepare and review SOPs/BMRs, monitor batch processes, and coordinate with QA for line clearance. The position requires 6–10 years in a regulated OSD setting and involves audits and data integrity initiatives.

Qualifications

• 6–10 years of experience in Production/QMS in a regulated OSD manufacturing environment.
• Exposure to USFDA audits and other international regulatory inspections preferred.
• 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.

Responsibilities

• Maintain and implement QMS documentation, SOPs, BMRs and related production records.
• Monitor batch execution and ensure compliance with approved procedures.
• Initiate and investigate production-related deviations; prepare CAPAs.
• Train production staff on cGMP, SOPs and QMS requirements; readiness for audits.
• Support root-cause analysis and data integrity initiatives.

Skills

cGMP knowledge

USFDA guidelines

Audit readiness

Analytical skills

Education

B.Pharm / M.Pharm in Pharmaceutical Sciences

Job description

Designation: Senior Executive

Function: Production

Functional Area: QMS Documentation

Job Role Summary: 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.

Job Profile

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.

Job Requirements

• 6–10 years of experience in Production/QMS in a regulated OSD manufacturing environment.
• Exposure to USFDA audits and other international regulatory inspections preferred.
• 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.

Work / Job Experience : 6-10 Years

Type of Experience : Production/QMS in a regulated OSD manufacturing environment

Academic Qualifications

• B.Pharm / M.Pharm in Pharmaceutical Sciences.

Job Post Link : https://tinyurl.com/2ejtcfsj

Full Time

India | Dadra and Nagar Haveli | Dadra

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Sun Pharmaceutical Industries Ltd