Assistant Manager / Deputy Manager - Quality Assurance

JobItUs; Bharuch District; On-site; INR 600,000 - 1,200,000; Full time

Job summary

JobItUs in Gujarat, India is seeking a QC/QA professional to ensure cGMP and GLP compliance, lead QC operations, review data and support regulatory audits. The role requires hands-on experience with HPLC, GC, UV-Vis, and wet chemistry, plus familiarity with QMS/GMP and SAP Laboratory modules.

The incumbent will guide analysts, manage investigations (OOS/OOT), stability studies, calibration, and method validation, while coordinating with QA, Production, and Regulatory Affairs to ensure audit

Qualifications

• Hands-on experience with HPLC, GC, UV-Vis and wet chemistry.
• Strong knowledge of QMS, QRM, GMP and laboratory compliance.
• Working knowledge of SAP Laboratory modules.
• Experience facing USFDA / EDQM / ANVISA audits is mandatory.
• Microbiology knowledge will be an added advantage.
• Good written and verbal English communication skills.

Responsibilities

• Ensure compliance with cGMP, GLP, FDA and regulatory requirements.
• Lead QC team operations, daily task allocation and technical troubleshooting.
• Review analytical raw data, HPLC/GC audit trails, SOPs and batch release documents.
• Lead investigations related to OOS, OOT, deviations and incidents, including RCA and CAPA.
• Manage stability studies, instrument calibration, analytical method validation/transfer and cleaning verification.
• Maintain reference standards and laboratory documentation.
• Train and guide QC analysts and reviewers.
• Coordinate with QA, Production and Regulatory Affairs for quality-related activities.
• Support regulatory inspections and maintain audit readiness.

Skills

HPLC

GC

UV-Vis

Wet chemistry

QMS

QRM

GMP

Laboratory compliance

USFDA audits

EDQM audits

ANVISA audits

Microbiology knowledge

English communication

Tools

SAP Laboratory modules

Job description

Key Responsibilities:

• Ensure compliance with cGMP, GLP, FDA and regulatory requirements.
• Lead QC team operations, daily task allocation and technical troubleshooting.
• Review analytical raw data, HPLC/GC audit trails, SOPs and batch release documents.
• Lead investigations related to OOS, OOT, deviations and incidents, including RCA and CAPA.
• Manage stability studies, instrument calibration, analytical method validation/transfer and cleaning verification.
• Maintain reference standards and laboratory documentation.
• Train and guide QC analysts and reviewers.
• Coordinate with QA, Production and Regulatory Affairs for quality-related activities.
• Support regulatory inspections and maintain audit readiness.

Technical Skills:

• Hands‑on experience with HPLC, GC, UV-Vis and wet chemistry.
• Strong knowledge of QMS, QRM, GMP and laboratory compliance.
• Working knowledge of SAP Laboratory modules.
• Experience facing USFDA / EDQM / ANVISA audits is mandatory.
• Microbiology knowledge will be an added advantage.
• Good written and verbal English communication skills.