Officer QMS - Production API

Ipca; Munger; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Ipca is seeking a Quality Assurance/Documentation professional for API manufacturing with expertise in GMP and QMS processes. The role focuses on maintaining regulatory-compliant documentation, handling deviations, and driving CAPA closures to ensure batch integrity and audit readiness.

The candidate should have experience with SOPs, BMR/BPR, change controls, and quality risk assessments, and participate in validation activities and shop-floor trainings to uphold high compliance standards.

Qualifications

• Prepare, review, and update SOPs, BMR, and BPR.
• Maintain real-time documentation on the shop floor to ensure data integrity and regulatory audits.
• Assist in tracking and closing document revisions and archiving obsolete manufacturing records.
• Initiate and investigate shop floor deviations, NCs, and OOS results.
• Conduct root cause analysis (RCA) using 5 Whys or Fishbone diagrams for production failures.
• Log, implement, and track CAPA to prevent recurrence of quality issues.
• Raise and evaluate Change Control requests; participate in Quality Risk Assessments (FMEA).
• Support validation activities (IQ/OQ/PQ) and Process Validation (PV).
• Conduct routine GMP and QMS training for shop floor operators and technicians.

Responsibilities

• Prepare, review, and update SOPs, BMR, and BPR.
• Maintain real-time documentation on the shop floor to ensure data integrity and regulatory audits.
• Assist in tracking and closing document revisions and archiving obsolete manufacturing records.
• Initiate and investigate shop floor deviations, NCs, and OOS results.
• Conduct root cause analysis (RCA) using 5 Whys or Fishbone diagrams.
• Log, implement, and track CAPA to prevent recurrence of quality issues.
• Raise and evaluate Change Control requests.
• Participate in Quality Risk Assessments (FMEA).
• Support validation activities (IQ/OQ/PQ) and PV.
• Conduct GMP and QMS training for shop floor operators and technicians.

Job description

Role & responsibilities

Documentation & Compliance

• Prepare, review, and update standard operating procedures (SOPs), Batch Manufacturing Records (BMR), and Batch Packaging Records (BPR).


• Maintain real-time documentation on the shop floor to ensure data integrity and compliance with regulatory audits.


• Assist in tracking and closing document revisions and archiving obsolete manufacturing records.

Deviation & Quality Event Management

• Initiate and investigate shop floor deviations, non-conformances (NCs), and out-of-specification (OOS) results.


• Conduct root cause analysis (RCA) using tools like 5 Whys or Fishbone diagrams for production failures.


• Log, implement, and track Corrective and Preventive Actions (CAPA) to prevent recurrence of quality issues.

Change Control & Risk Management

• Raise and evaluate Change Control requests for any modifications to production processes, equipment, or materials.


• Participate in Quality Risk Assessments (FMEA) related to production line changes or new product introductions.

Validation & Training

• Support validation activities, including Equipment Qualification (IQ/OQ/PQ) and Process Validation (PV).


• Conduct routine GMP and QMS training for shop floor operators and technicians to maintain high compliance awareness.

Preferred candidate profile

3 to 5 years of direct experience in an API manufacturing facility with a proven track record in a USFDA-approved environment.