Officer QMS - Production API

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.