Assistant Manager / Deputy Manager - Quality Control

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

Job summary

JobItUs in India is seeking a QC lead to ensure compliance with cGMP, GLP and regulatory standards. The role involves leading the QC team, reviewing analytical data, and guiding investigations related to OOS/OOT and deviations. You will coordinate with QA, Production and Regulatory Affairs, and support regulatory inspections.

Strong expertise in HPLC/GC and GMP is required. Candidates should have hands-on QC laboratory experience, proficiency in SAP laboratory modules, and excellent written and

Qualifications

• Experience ensuring cGMP, GLP, FDA compliance and regulatory readiness.
• Auditing experience with USFDA, EDQM and ANVISA.
• Strong written and verbal English communication skills.
• Hands-on QC lab operations and data review experience.

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

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.