Sr. Executive - QC Reviewer (API) USFDA Plant

Ipca; Munger; On-site; INR 1,200,000 - 2,100,000; Full time

Job summary

Ipca is seeking an experienced QC professional to audit and approve data for APIs and raw materials, ensuring regulatory compliance. The role involves leading QMS investigations for OOS/OOT and deviations, and maintaining instrument audit trails to support USFDA inspections.

The ideal candidate has 8–10 years of QC experience in a USFDA-approved API plant, with hands-on calibration of HPLC/GC and strong GMP understanding. Join a high-standard QC team ensuring data integrity and product quality.

Qualifications

• 8–10 years of QC experience in a USFDA-approved API plant.
• Experience reviewing and approving data, records, and calculations.
• Strong familiarity with audit trails and GMP/compliance requirements.

Responsibilities

• Data Review: audit and approve raw data, calculations and records for APIs and materials.
• Audit Trails: review electronic instrument logs (Empower 3) to prevent data gaps.
• QMS Investigations: lead phase-1 investigations for OOS, OOT and deviations.
• Audit Readiness: maintain logs, calibrations (HPLC, GC) and procedures for USFDA inspections.

Skills

Quality Control

Analytical Testing

Audit & Compliance

Tools

HPLC

GC

Empower 3

Job description

Role & responsibilities

• Data Review: Audit and approve raw data, calculations, and analytical records for APIs, stability, and raw materials.
• Audit Trails: Perform mandatory reviews of electronic instrument audit trails (Empower 3) to prevent data gaps or manipulation.
• QMS Investigations: Leading phase-1 laboratory investigations for OOS, OOT, and deviations.
• Audit Readiness: Maintain logs, instrument calibrations (HPLC, GC), and procedures to remain continuously ready for USFDA inspections.

Preferred candidate profile

8 to 10 years QC experience in a QC USFDA-approved API plant.