Assistant Manager - QC HPLC/GC

Ipca; Munger; On-site; INR 1,800,000 - 2,400,000; Full time

Job summary

Ipca is seeking a Lead (HPLC/GC) in an USFDA-approved API plant to supervise chromatography operations and uphold data integrity using ALCOA+ principles.

Responsibilities include leading investigations for OOS/OOT, drafting SOPs, and managing daily lab workflows while coaching analysts and ensuring readiness for regulatory audits.

Qualifications

• Oversee routine testing, troubleshooting, and calibration for HPLC, UPLC, and GC systems.
• Enforce ALCOA+ data integrity guidelines and review electronic audit trails.
• Lead investigations for OOS/OOT and deviations; implement CAPAs.
• Draft and approve SOPs, STPs, specifications, and method validation protocols.

Responsibilities

• Manage daily testing workflows and shift allocations for analysts.
• Provide technical coaching and supervision to the team.
• Ensure compliance with regulatory audits and internal quality standards.

Skills

Chromatography supervision

Lab leadership

Regulatory compliance

Data integrity

Tools

HPLC

UPLC

GC

Empower 3

Job description

Role & responsibilities

• Chromatography Supervision: Oversee routine testing, troubleshooting, and calibration for HPLC, UPLC, and GC systems using software like Empower 3.
• Regulatory Compliance: Enforce ALCOA+ data integrity guidelines, review electronic audit trails, and actively defend the lab during USFDA/MHRA audits.
• QMS & Investigations: Lead scientific investigations for OOS (Out of Specification), OOT (Out of Trend), deviations, and implement robust CAPAs.
• Documentation: Draft and approve SOPs, Standard Testing Procedures (STPs), specifications, and method validation protocols.
• Team Leadership: Manage daily testing workflows, allocate analysts to shifts, and provide technical coaching.

Preferred candidate profile

Preferred Candidate Profile for an Lead (HPLC/GC) in a USFDA-approved API plant